Job Openings
This page includes job openings and posting dates
Please Note
Get Your Jobs Posted
ASQ Denver posts jobs a service to our members. There is no charge for posting jobs. If you have a job you would like to have posted, please send your job notice to our Internet llaiason, Ken Pitt. Please include contact iunformation in the body of the job notice. I get job openings all the time that have been forwarded several times, and any contact info is long gone because it was not included in body of the job posting.
Please Note: No contact information = no job posting.
A Few Tips On Formatting
- Don't use several forms of text emphasizing at once. Simple bolding is ok, but adding more forms of emphasis, such as all caps, underlining, and italics only makes your text less readable instead of more. If you use it all, your text just basically becomes a big black blob that is very hard to read.
- Use bullets for lists of things that are not hierarchal and numbers or letters for things that are. That is, if things are to appear in a specific order, use numbers or letters, and if things are not, use bullets.
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- Make any links included in the job notice live if you want them to be live.
Thanks, Ken
Quality Engineer Associate
08/29/10
Department : Operations
Status: Exempt
PURPOSE OF JOB : The Quality Engineer Associate will be responsible for creating, updating, and maintaining quality system documents as well as support engineering verification and validation testing activities. They will be expected to review, approve, and implement changes to quality system document and records produced by document control, production, incoming inspection and work with engineers and designers to research and test new and existing designs for new product development.
MAJOR DUTIES AND RESPONSIBILITIES :
- Control of quality system records, revisions, including accurate and timely storage/retrieval.
- Control of the distribution and accuracy of all the documents used in Manufacturing, Product Development and QA/QC of company products.
- Assist in QA/QC, Production and Product Development personnel in formatting all quality system documents. Provide word processing services as required to prepare all such documentation.
- Assist in the writing and execution of system validation plans and protocols for tools and fixtures used in manufacturing.
- Assist in timely processing of complaint, nonconformity, returned goods and Corrective and Preventive Action (CAPA) activities including the processing, database management and data trending. Perform incoming inspection, finish good inspections and final product release for distribution.
- Development of documentation to support R&D, verification and validation such as component specifications, installation, operation, and performance qualification protocols.
- Support research of competitive technologies in addition to medical, technical, and biomedical developments related to company products.
- Execution of verification and process validation protocols including creation and maintenance of test plans, test procedures, test data, test logs and test reports.
- Communicate test data/results verbally or in written form.
- Research components, tools, equipment to support R&D and product development.
EDUCATION / EXPERIENCE REQUIREMENTS :
- Undergraduate degree or equivalent of education and work experience.
- Minimum of three years combined experience in quality and regulatory systems within the regulated industry, preferably with medical devices.
OTHER QUALIFICATIONS :
- Experience/understanding of cGMP, QSR and ISO 13485:2003 requirements.
- Good technical writing skills.
- Strong computer skills, including Word and Excel
- Detail-oriented and strong organization skills
Send resume to: jmorton@crosstreesmedical.com
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Software QA Engineer
08/29/10
Baxa Corporation was founded in 1974 with a mission to develop innovative products of superior quality for hospital pharmacies nationwide. More than 35 years later, the Baxa name is synonymous with practical fluid-delivery solutions for both the pharmacy and nursing environments, and the company's reach is now global. Our first product, the Exacta-Med ® Oral Dispenser, remains the industry standard for safe, simplified delivery of oral liquid drugs.
To add to our team of talented, dedicated associates, Baxa is currently seeking a Software Quality Assurance Engineer for our corporate office in Englewood, CO. T he Software Quality Assurance Engineer assures the highest possible quality of products through the product lifecycle by: Creating and executing test plans and test cases (black box) based upon stated requirements; Tracking and documenting defects and, as appropriate, recommending design modifications; and Assessing and improving software quality activities and procedures.
Essential Functions:
- Generates test plans and test cases (black box) based upon requirements, executing both functional and performance based tests
- Executes test cases manually, with automation or other tools as necessary
- Formally tracks defects detected during testing or reported by other members of team, and keeps trace data that ties the tests to the requirements
- Ensures that software/computer system implementation meets the requirements for validation
- Participates in technical design and code reviews with development
Specific responsibilities may include, but are not limited to :
- Assist in creating, performing and documenting appropriate test plans and protocols
- Recommending changes or additions to products that facilitate testing
- Documenting results according to regulatory and company expectations
Knowledge, Skill and Ability :
- Intermediate knowledge of standard SQA methodologies and practices
- Intermediate understanding of software/SDLC components and models
- Intermediate understanding of software/system configuration management and change control
- Excellent verbal and written communication skills
- Proficient PC skills and the ability to apply these tools to data analysis
- Ability to write testing scripts (NT scripts, Perl, TCL/TK, etc.)
- Knowledge of Object Oriented programming concepts
- Experience with automated testing tools
Education/Experience
- BA/BS in computer science or relevant technical area
- 3-5 years experience in a software testing environment, preferably FDA regulated
Baxa offers a full range of benefits to meet associates' needs and those of their families, and we take great pride in making Baxa one of the best places to work in Colorado – and everywhere else. For immediate consideration, please visit our careers website at www.baxa.com/aboutus/careersbaxa or click on the following link: http://tinyurl.com/26wz3hs .
Baxa Corporation is an Affirmative Action / Equal Opportunity Employer.
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Quality Specialist
08/20/10
Founded in 1970, the Colorado Foundation for Medical Care (CFMC) has grown to be one of the most experienced and respected medical quality improvement organizations (QIOs) in the United States. CFMC, the official QIO for the state of Colorado since 1974, works collaboratively with government programs, health providers, and managed care companies to improve the quality of health care. To learn more about CFMC, check out our website at www.CFMC.org . EOE.
Position Title: Quality Specialist
Description:
Do you enjoy analyzing and synthesizing details to understand and assess the larger picture? Do you like translating principles, standards, and other requirements, and applying them to a wide-range of situations and processes? If you have experience with quality management principles, methodologies, tools, and standards, and exceptional writing skills, we would love to hear from you. The position entails auditing, document and record control, quality management system maintenance and improvement, employee training and coaching, report and document development, and strong attention to details.
Requirements:
Requires Bachelors degree or commensurate experience. Two to three years experience in quality management. Formal quality management/performance improvement methodology training/experience.
Internal auditor training on ISO 9000 and other applicable standards and requirements. Ability to write clear, accurate documents. CPHQ or other quality certification or eligible for certification within 18 months of employment preferred.
Part-Time Position - 20 hours/week
Salary Range: $23,358 - $29,203
Email cover letter and resume to humanresources@cfmc.org . Please let us know that you found the job posting on the ASQ website.
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Quality Manager
08/04/10
Power your life
Vestas offers you challenging career opportunities in a global organization. As the world's leading supplier of wind power solutions we have installed more than 39,000 wind turbines in 63 countries. We are currently more than 20,000 employees, and we are eager to welcome new dedicated colleagues. Care to join us?
Company & Department
Vestas Nacelles America, Inc. / Brighton , CO
Quality Department
Responsibilities and Tasks
Plans, coordinates, and directs quality program designed to ensure quality control and quality assurance of the production of products consistent with established standards by performing the following duties personally or through subordinate supervisors.
Safety Roles and Responsibilities
- Conduct Safety Walks on designated basis and record event and findings in the Nacelles Safety Walks Database. Production Related – Monthly; Admin - Quarterly
- Conduct one-to-one Safety Contacts with hourly Team members
- Assess task performance in regards to safety for subordinate management
- Review investigative reports and delegate appropriate resources for mitigation efforts
- Begin meetings with a safety note or message
- Participate in Team Member HSE area checks on a periodic basis
Essential Duties and Responsibilities Other duties may be assigned.
- ISO9001 Management Representative
- PBU Quality deployment
- Quality principles—Q on the agenda
- Internal audits
- Customer audit handling
- Compliance with control plans through SPC and capability
- Budget accountability
- Compliance using PQA and product/process verification
- Support validation of changes in products and processes
- Competence validation
- Quality improvement project portfolio management on factory level
- Elimination of recurring product defects
- Ensure best practice sharing
- Formulates and maintains quality objectives complementary to corporate policies and goals.
- Satisfy requirements to achieve ISO 9001 implementation as well as maintaining such certification.
- Act in the capacity of “lead auditor” for the quality team.
- Implementation of maintenance of the Nacelles Management System.
- Interprets quality philosophy to key personnel in organization.
- Performs quality engineering reviews of design documentation for compliance with stated requirements, including vendor quality manuals and company quality records.
- Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
- Reviews all data obtained during all quality control and quality assurance activities to ensure consistency with company policies and procedures.
- Keeps management team abreast of significant issues or developments identified during quality activities and actions being taken to improve the situation.
- Prepares and presents program information to the management team.
- Maintains a working knowledge of government and industry quality codes and standards.
- Plays active role on quality management teams within organization.
- Designs and implements quality training programs to key personnel in conjunction with managers.
- Investigates and adjusts customer complaints regarding quality.
Supervisory Responsibilities
Manages approximately 10 employees in the Quality department. Responsible for the overall direction, coordination, and evaluation. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Qualifications and Work Experience
- 5 years experience managing 3 or more people as the senior quality official in an electronics or automotive manufacturing setting
- Six Sigma Green Belt
- Bachelors degree in business, operations, or related discipline
- ISO 9001 Experience
- Knowledge of calibrated tools (mechanical and electrical)
Preferences:
- Six Sigma Black Belt
- Certified Lean Master
- ASQ certified
What we offer
Vestas offers outstanding employee benefits including: 4 weeks annual vacation accrual, 100% paid insurance premiums for employee and family including medical, dental, vision, prescription; 100% paid premiums for life, ADD and LTD; 401k with company match, and global opportunities for training and development.
Additional Information
TO APPLY: PLEASE EMAIL YOUR RESUME TO: Gary Held , gahel@vestas.com
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Quality Engineer Associate
08/03/10
Contract Engineering Services, Inc.
Quality Engineer Associate
- Bachelor's degree in a technical discipline or equivalent experience.
- Minimum related work experience of 3 to 5 years in Class II/III medical device manufacturing.
- Must have proven proficiency in problem analysis, testing and laboratory skills.
- Ability to work within a changing environment.
- Ability to work together with a wide variety of personnel on all levels and utilize constructive confrontation techniques when faced with challenging issues.
- ASQ Certified Quality Engineer is a plus
- Statistics knowledge
- Knowledge of regulatory requirements (e.g., FDA, ISO) as required for the position.
- Possess methodical documentation skills
- Excellent presentation skills
- Able to communicate across functional lines
Please send resume to mailbox@cesdenver.com Phone: 303-757-8500
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QA Lead Inspector/Supervisor
08/03/10
Genesee BioMedical, Inc.
Genesee BioMedical, Inc. a world-class manufacturer of cardiac surgery instruments and devices has an immediate opening for a Split or 2 nd Shift Quality Assurance Lead Inspector/Supervisor.
Person applying must have attention to details and work independently with minimal supervision.
Position Title: QA Lead Inspector/Supervisor
Responsibilities:
Supervise and schedule duties of Split or 2 nd Shift QA staff.
Preferred Education and Work Experience Qualifications:
- Minimum of 3 - 5 years combined experience in quality and manufacturing.
- Familiarity with quality assurance methods and techniques; attention to detail; familiarity with FDA & ISO requirements. Supervisory experience helpful.
- High School diploma or equivalent and work experience in a quality related field.
- Familiar with MS Word helpful
Position Objectives:
- Perform QA and regulatory support activities.
- In Process & Incoming Materials Inspecting
- Work In clean room environment
- Maintain systems related to quality assurance and regulatory compliance.
Candidates should forward their Resume with Salary History to:
jpotter@geneseebiomedical.com
Mail: Genesee BioMedical, Inc.
1308 South Jason Street
Denver , CO 80223
Attn: QA Dept.
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QA Technician/Inspector
08/03/10
Genesee BioMedical, Inc.
Genesee BioMedical, Inc. a world-class manufacturer of cardiac surgery instruments and devices has an immediate opening for a Split or 2 nd Shift Quality Assurance Technician/Inspector.
Person applying must have attention to details and work independently with minimal supervision.
Position Title: QA Technician/Inspector
Responsibilities:
Preferred Education and Work Experience Qualifications:
- Minimum of 2 - 3 years combined experience in quality and manufacturing. Good understanding of standard quality control/ quality assurance methods.
- High School diploma or equivalent and work experience in a quality related field.
- Familiar with MS Word helpful
Position Objectives:
- Entry Level Position
- Perform QA and regulatory support activities.
- In Process & Incoming Materials Inspecting
- Work In clean room environment
- Maintain systems related to quality assurance and regulatory compliance.
Candidates should forward their Resume with Salary History to:
jpotter@geneseebiomedical.com
Mail: Genesee BioMedical, Inc.
1308 South Jason Street
Denver , CO 80223
Attn: QA Dept.
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Child Health Plan QI / Process Improvement Coaching Role
08/03/10
The Department currently has an opportunity for a professional to bring strong process improvement experience and skills to the Medicaid and CHP+ Program Offices. This position has specific responsibility for assisting the Quality Improvement efforts of the Child Health Plan+ (CHP+) Division, in a collaborative / partnering relationship. In addition, this position is responsible for educating, coaching and promoting the use of Process Improvement tools to improve care and services Medicaid and CHP+ clients receive. This is an exciting opportunity to work as part of a team of internal coaches, leading our Office to improved business performance and project success. If you are interested or have questions, please contact John Barry, Deputy Director of Medicaid, at john.r.barry@state.co.us . Since this is an already posted position, responses will be limited to email communication. Additional information and an application can be accessed here .
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Long-Term Care QI / Project Management Coaching Role
08/03/10
The Colorado Department of Health currently has an opportunity for a professional to bring strong project management experience and skills into our Medicaid and CHP+ Program Offices. This position has specific responsibility for assisting the Quality Improvement efforts of our Long-Term Care Division, in a collaborative / partnering relationship. In addition, this position is responsible for educating, coaching and promoting the use of Project Management skills to improve Office efficiencies. This is an exciting opportunity to work as part of a team of internal coaches leading our Office to improved business performance and project successes. If you are interested or have questions, please contact John Barry, Deputy Director of Medicaid, at john.r.barry@state.co.us . Since this is an already posted position, responses will be limited to email communication. Additional information and an application can be accessed here .
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Senior QA Specialist I - SQA
07/28/10
Posting Title Senior QA Specialist I - SQA
Requisition Number 1442BR
Location Golden, CO
Position Type Regular Employee
Job/Research Summary
The primary purpose of the Software Quality Assurance (SQA) role is to define, document, implement, and manage NREL's SQA Program to support a dynamic and evolving range of research and business application systems running on diverse platforms. The SQA Program consists of the systems, processes, and tools needed to effectively implement SQA at all levels including organizations, projects, and initiatives.
This is a senior level position that works directly with Product Line Managers, Project Managers, Line Managers, and others to determine the applicability and deploy SQA Program requirements. The SQA Program includes all activities associated with software development (e.g., requirements management, planning, design, configuration management, testing, documenting, continuous improvement, SQA assessments, etc.).
The program will be based on existing industry consensus standards such as the CMMI for Development and ISO 9001.
Job Duties
- Develop, implement, and manage a systematic approach to SQA including the development of applicable policies, procedures, standards, and best business practices that meet the requirements of NREL, federal, state, and international consensus standards for in-house developed and COTS software.
- Maintain an inventory and conduct risk assessments for in-house developed software applications with an emphasis on safety control systems.
- Serve as technical resource and subject matter expert for software system developers on SQA functions. Train software development staff in the use and application of applicable SQA methods and tools. Consult with individuals to establish effective SQA approaches for individual projects. Support customers by helping to define and participate in acceptance testing of systems prior to implementation. Serve as the Lab's resource for defining, identifying, and interpreting applicable requirements and best practices to be incorporated into software development activities.
- Oversee software vendors/contractors to evaluate and monitor their SQA programs and ensure that NREL requirements are met.
- Periodically monitor software products and active software development projects to verify compliance with laboratory policies, procedures, and standards to facilitate early detection of problems that could affect the reliability, maintainability, availability, integrity, safety, security, and/or usability of software products.
- Assist software developers in evaluating the quality of their outputs and the risks to their projects.
Required Education and Experience
Relevant Master's Degree and 7 years experience or equivalent relevant education/experience.
Additional Basic Required Knowledge, Skills and Abilities
- BS/BA degree required in computer science, information sciences, or related field or equivalent relevant experience.
- Minimum of 10 years relevant experience including at least 5 years of recent experience implementing SQA in diverse development environments. Knowledge of and experience in software engineering is required (e.g., software requirements development/management, software design and architecture, software coding standards, software testing, automated software test frameworks, fault-tree analysis, software bug tracking, software configuration management).
- Must have in-depth knowledge of software development methodologies such as RAD, Scrum, Team SW Process, Extreme Programming, RUP, Agile, etc. Experience in SQA program or project management, policy and procedure development, and performing SQA assessments. Must have experience in implementing SQA standards such as the CMMI-DEV. Ability to drive improvements across organizations and systems is required. Excellent consultative, interpersonal, facilitation and communicative skills are required and essential to successful job performance. Incumbent will work in an environment requiring initiative, independent judgment, and decision making. The ability to cope with ambiguity and use facilitation, team building, and coaching skills is also required.
Preferred Qualifications
Relevant advanced degree and/or a certification in quality management (e.g., CSQE), software engineering, or a related field. Experience applying software engineering and control principles in a research environment. Experience in leading SCAMPI type appraisals.
Knowledge of ISO 9001 quality standard and its application to software.
EEO Policy
NREL's policy is to provide equal employment opportunities to all qualified persons without regard to race, age, color, sex, religion, national origin, marital or veteran status, or any other legally protected status.
Interested candidates should contact garyvansuch@gmail.com
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Director of Quality Assurance
07/28/10
High Technology Company in SW Denver area has immediate opening for an individual to lead and manage QA department.
Qualifications for this position are:
- College degree, ASQ certification
- 4 + yrs. ISO9001/AS9100 environment
- Hardware and Software Quality Program experience required
- Manufacturing environment experience required
- Military avionic background a plus
- Electro-Optical/Mechanical/Software Configuration Mgmt experience are a plus
- Statistics knowledge a plus
Company is a high-performance, team-oriented company that offers a competitive salary and excellent benefits. Please respond to barbs@ophir.com
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Quality Assurance Supervisor - Part Time
07/16/10
Position Title: Quality Assurance Supervisor - Part-time (# hrs/wk to be determined)
Description: Small medical device company is in need of a Quality Assurance professional to provide assistance in assuring that the Quality Management System stays compliant with existing procedures and policies. This individual will be instrumental in assessing the company current and future quality and regulatory needs. Quality System responsibilities will include Document Control processing, Complaint Handling, Quality Inspection activities, etc.
Requirements: Medical Device Quality Assurance experience
Salary Range: Negotiable - Part-time # hrs/wk to be determined
Email cover letter and resume to Tom Siirola - tcsiirola@xanacare.com
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Job Title: Regulatory Affairs Manager (US Submissions)
Job Summary:
This position will focus primarily on the preparation, publication, quality control, and delivery of paper and electronic components of all submissions to introduce new products to the United States. Incumbent will prepare, submit, track, index and archive paper and electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials.
Key Duties and Responsibilities:
- Function as key regulatory affairs point person for all US new product submissions.
- Prepare document packages for regulatory submission, including FDA 510(k), IDE, PMA(S), STED, Design Dossiers, and Device License Applications.
- Work with Clinical Affairs, Marketing and Product Development to ensure that regulatory requirements for assigned projects are met.
- Serve as a Regulatory representative to Project Teams as needed for assigned projects or products.
- Assistance in the development of submissions through the review process.
- Tracking and facilitating the progress of submissions through the review process.
- Review of protocols and reports to support regulatory compliance and submissions.
- Review device labeling and advertising materials for compliance with FDA submissions and applicable regulations.
- Interact with various regulatory agencies to accomplish product clearances.
- Participate on development teams and communicate regulatory requirements for product development.
- Review and approve test protocols and reports to support regulatory submissions.
- Review device labeling and advertising materials for compliance with submissions and applicable regulations; recommend changes when appropriate.
- Organize and maintain RA documentation and collaterals.
- Assist in developing systems to improve regulatory efficiency and improve quality.
- Keep updated on regulatory authorities’ requirements on technical/format aspect of submissions and ensure incorporation into Spectranetics standards.
Education/Experience Necessary:
- BA/BS or equivalent relevant work experience.
- 3-5 years experience in a regulatory submission experience.
- Thorough understanding of regulatory requirements and relevant government regulations.
- Proficient in establishing priorities and setting/executing project plans.
- Ability to handle multiple projects and competing timelines.
- Excellent interpersonal, verbal and written communication.
This job description is intended to describe the general nature and level of work assigned to individual filling this position. This is not intended to be an exhaustive list of all responsibilities, duties or skills required. This job description is subject to change as the needs and requirements of the department and business change.
Please apply online at: www.spnc.com
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Regulatory Affairs Manager
07/01/10
Job Summary: Regulatory Affairs Manager (International Submissions)
Job Summary:
This position will focus primarily on the preparation, publication, quality control, and delivery of paper and electronic components of all submissions to introduce new products to international markets. Incumbent will prepare, submit, track, index and archive paper and electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials.
Key Duties and Responsibilities:
- Function as key regulatory affairs point person for all international submissions and CE applications.
- Prepare document packages for regulatory submission, including Shonins, FDA 510(k), IDE, PMA(S), STED, Design Dossiers, and Device License Applications.
- Work with Clinical Affairs, Marketing and Product Development to ensure that regulatory requirements for assigned projects are met.
- Serve as a Regulatory representative to Project Teams as needed for assigned projects or products.
- Assistance in the development of submissions through the review process.
- Tracking and facilitating the progress of submissions through the review process.
- Review of protocols and reports to support regulatory compliance and submissions.
- Review device labeling and advertising materials for compliance with FDA submissions and applicable regulations.
- Interact with various regulatory agencies to accomplish product clearances.
- Participate on development teams and communicate regulatory requirements for product evelopment.
Review and approve test protocols and reports to support regulatory submissions.
- Review device labeling and advertising materials for compliance with submissions and applicable regulations; recommend changes when appropriate.
- Organize and maintain RA documentation and collaterals.
- Assist in developing systems to improve regulatory efficiency and improve quality.
- Keep updated on regulatory authorities’ requirements on technical/format aspect of submissions and ensure incorporation into Spectranetics standards.
Education/Experience Necessary:
- BA/BS or equivalent relevant work experience.
- 3-5 years experience in a regulatory submission experience.
- Thorough understanding of regulatory requirements and relevant government regulations.
- Proficient in establishing priorities and setting/executing project plans.
- Ability to handle multiple projects and competing timelines.
- Excellent interpersonal, verbal and written communication.
This job description is intended to describe the general nature and level of work assigned to individual filling this position. This is not intended to be an exhaustive list of all responsibilities, duties or skills required. This job description is subject to change as the needs and requirements of the department and business change.
Please apply online at: www.spnc.com
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Clinical Engineer
07/01/10
JOB TITLE: Clinical Engineer
DEPARTMENT: CLINICAL - TECHNICAL
DEPARTMENT HEAD : Christine Menapace
REPORTS TO : Phil Segel-Director Clinical – Technical Service
PRIMARY FUNCTION:
Provide acute and sustaining engineering support to internal and external customers. Support takes the form of but is not limited to assisting customers in the management of challenging technical cases arising from early product validation experience through the later life cycles of various products, develop software/hardware tools for advanced diagnostics for field issues, analyzing trends from the issue tracking process related to patient, hardware and software issues and investigating these trends
DUTIES:
I. Provides technical input into the management of systems issues in early product development.
II. Develops and executes investigations related to patient, hardware, software or overall systems level problems based on trending from the complaint handling process and other avenues of customer feedback.
III. Provides feedback to the D & D and Quality organization regarding field reliability and patient-related issues.
IV. Analyzes and presents meaningful KPIs related to field problems.
V. Develops technical briefs for the Education & Training and Product Management groups on field performance issues in conjunction with CLTD based resources.
VI. Develop software/hardware bench-level tools in conjunction with D & D for the evaluation of field issues for the field organization, including tools for implant integrity assessment. Gathers normative data on these tools and sets parameters for interpretation of field data .
Provides technical training to the field organization and other internal groups (e.g. customer service) to enhance and maintain the technical training of these company personnel.
- This training may take the form of oral presentations or the development of written materials.
- This training will include both basic sciences (e.g. basic electronics) and basic product functionality
• Provide technical support regarding the cochlear implant - assistive listening device interface, and evoked potential measurements to customers as needed.
• IX. Support trials of new products through various phases of development in order to develop post-launch monitoring intervention plans .
IX . Maintain compliance with federal regulations on GMPs and Quality Systems for software/hardware tools developed in house
Experience:
- BS in Engineering (or equivalent) with at least 5 years electronics product development, or an MS in Engineering (or equivalent) with at least 2 years electronics product development
- Experience with cochlear implants or other implantable medical devices preferred. Effective verbal and written communication skills.
- Extensive (current) experience using software and hardware measurement equipment.
- Proven record of effective vendor interaction and ability to interact effectively with allied health professionals.
SPECIALIZED KNOWLEDGE & SKILLS
- Must have an understanding of the application of electrical stimulation for biomedical prostheses.
- Must have facility with basic software based bench tools (e.g. Labview, Visual Basic, C++)
- Must have a fundamental understanding of electromedical diagnostics.
- Must be able to work in a fast paced environment and foster constructive relationships with internal and external customers.
- Must be able to apply laboratory-based practices/procedures to field problems
- Must be willing to travel.
Education and Training
Master's degree in systems, electrical or biomedical engineering
Physical Environment/Working Conditions
- Travel out of the Cochlear America's office @5 days/ month
- Required to be able to carry necessary equipment (up to 40lbs) into the field
Responsibility for Personnel
- Direct Supervision: NA
- Indirect Supervision: NA
Internal Contacts
- D & D Organization
- Quality Organization
- Product Management
- Field Organization
External Contacts
- Cochlear Implant Centers
- 3 rd Party Manufacturers
To apply, please contact:
Phil Segel
Director Clinical / Technical Services & Quality Systems
Cochlear Americas
303-524-7181
psegel@cochlear.com
Quality Engineer Associate
06/06/10
POSITION SUMMARY :
Under normal supervision, assists in quality engineering and laboratory management work to achieve and maintain the highest possible product quality levels and regulatory compliance. Supports team efforts to improve product quality and product complaint handling BU wide. Frequently uses and applies technical standards, principles, theories, and concepts. Understands the company's practices, policies, and basic therapies and uses the knowledge effectively in its application.
- Assists in the monitoring and trending of product complaint quality data. This includes developing and implementing systems for tracking, analyzing, reporting and problem solving.
- Analyzes product complaints and ensures that systematic problem solving methods are employed and results are properly documented.
- Interfaces with customers and sister companies on product complaint and vigilance reporting matters
- Monitors and supports compliance to regulatory and company requirements.
- Assists in the preparation, filing and tracking of product MDRs to ensure on-time reporting, completeness and high levels of regulatory compliance.
- Coordinates and drives all aspects of product complaint handling for both domestic and international manufactured products within the BU.
- Assist in managing Commercial QA Laboratory to GLP requirements and providing guidance to laboratory personnel in product problem investigations and complaint handling.
- Works with Human and Bovine blood and blood products.
- Offers recommendations and participates in efforts to improve product quality, complaint investigations and customer feedback in order to maximize customer satisfaction and service.
- Evaluates and implements protocols and methods for all aspects of product complaint handling to ensure compliance with companies quality standards and regulatory requirements.
- Uses ingenuity in analyzing product technical problems and development of testing methodologies and/or protocols.
- Understands and implements FDA or other regulatory requirements as necessary.
- Frequently seeks and uses information from other BU companies to improve efficiencies and overall complaint closure times.
- Performs other related duties as required in support of company and departmental objectives.
Education and Qualifications:
- Bachelor's degree in a technical discipline or equivalent experience.
- Minimum related work experience of 3 to 5 years in Class II/III medical device manufacturing.
- Must have proven proficiency in problem analysis, testing and laboratory skills.
- Ability to work within a changing environment.
- Ability to work together with a wide variety of personnel on all levels and utilize constructive confrontation techniques when faced with challenging issues.
- ASQ Certified Quality Engineer is a plus
- Statistics knowledge
- Knowledge of regulatory requirements (e.g., FDA, ISO) as required for the position.
- Possess methodical documentation skills
- Excellent presentation skills
- Able to communicate across functional lines
Please apply online at:
www.soringroup-usa.com
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