Quality Systems Engineer III - Lead Auditor
Quality Systems Engineer III - Lead Auditor
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Job Description
The Quality Engineer III collaborates crossfunctionally to support the production factories lines and cells during the manufacturing process of CONMED medical devices. The Quality Engineer III supports operations with the objective of maintaining high quality standards for the product manufacturing process and the conformance to the CONMED Quality Management System and the regulatory requirements.
Key Duties & Responsibilities:
- Develop Implement and maintain quality system processes and procedures to ensure compliance to all domestic and international standards or requirements. (EN ISO 13485/CMDCAS/MDD & FDA QSR).
- Keep current on all applicable best practices and statutory regulations governing the design procurement manufacture marketing and distribution of medical devices.
- Demonstrate leadership and initiative to plan and perform engineering assignments that support company goals and objectives.
- Apply Quality Engineering tools such as Failure Mode & Effects Analysis (FMEA) Fault Tree Analysis (FTE) Root Cause Analysis and Design of Experiment (DOE) to the development of new products or processes; and in solving process/productrelated problems. Promote and apply the DMAIC/PDCA Methodology for product/process/system improvements.
- Direct and guide the Quality Technicians in the factory.
- Provide support to Operations on quality assurance/control issues including but not limited to: Daytoday troubleshooting situations Communication/escalation of key quality issues NCR/NCP management complaint management CAPA management change management risk management quality objectives management through data analysis statistical analysis and training/consultation on quality concepts quality technology tools and investigation techniques.
- Collaborate with manufacturing engineering to develop a strategy for process assurance activities related to new product launch review/approve process assurance documents (IQs OQs PQs VEs Test Method Validations).
- Review/approve change notices associated with the introduction of process documentation related to new product launch (tooling drawings work instructions process travelers control plans and inspection procedures).
- Collaborate with manufacturing engineering/R&D to develop process risk documents (PFMEAs).
- Review/approve Design Transfer Matrix (DTM) to ensure all critical product characteristics have been addressed prior to product launch.
- Direct the resolution of quality issues by fostering crossfunctional partnerships through effective communication engagement activities and influencing behaviors.
Minimum Requirements:
- Bachelors degree in Engineering or related technical discipline
- 5 years related experience in Quality Assurance or Quality Engineering with a bachelors degree; 3 years with a masters degree.
Other Attributes:
- Thorough understanding of 21CFR820/ISO13485/ISO14971
- Knowledge of quality principles systems methods problemsolving tools and statistical principles
020 Travel
This position is not eligible for employer based sponsorship. Disclosure as required by applicable law the annual salary range is. The actual compensation may vary based on geographic location work experience education and skill level. The salary range is CONMEDs good faith belief at the time of this posting.
Benefits:
CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.
- Competitive compensation
- Excellent healthcare including medical dental vision and prescription coverage
- Short & long term disability plus life insurance cost paid fully by CONMED
- Retirement Savings Plan 401K) CONMED matches your contributions dollar for dollar with the potential for up to 7 per pay period
- Employee Stock Purchase Plan allows stock purchases at discounted price
- Tuition assistance for undergraduate and graduate level courses
Know someone at CONMED
Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!
CONMED is an Equal Opportunity Employer & an Affirmative Action Employer. CONMED is a strong advocate of workforce diversity. All qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex sexual orientation gender identity national origin disability citizenship status or veteran status. The Know Your Rights: Workplace Discrimination is Illegal Poster and Pay Transparency Nondiscrimination Provision reaffirm this commitment.
Colorado Residents: In any materials you submit you may redact or remove ageidentifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
If you feel you need a reasonable accommodation pursuant to the ADA you are encouraged to contact us atoption #5.
Employment Type
Full-Time
