Medical Device Quality Engineer; Sustaining Engineering
Location: Town of East Greenbush
Medical Device Quality Engineer (Sustaining Engineering)
We are currently looking to fill a Quality Engineer position on the Medical Device Sustaining Engineering QA team. This position will provide Quality Assurance oversight and ensure compliance in the support of combination device development life cycles.
Typical Responsibilities- Review design and development paperwork and records for compliance to internal procedures and regulations.
- Ensure accurate justification of statistical analysis and hypothesis testing.
- Review technical reports as well as documents for Design History Files.
- Participate in device risk management activities including UFMEA, DFMEA, PFMEA.
- Aide in establishing statistical controls in development and transfer to manufacturing processes.
- Review and coordinate with QA Validation for all test method and design validations.
- Review activities related to Design Verification and Design Transfer of Medical Devices.
- Ensure work product meets regulations.
- Support scientific, complaint, and test failure investigations.
- Perform data trend analysis, participate in Phase Reviews, write Quality Procedures, perform data/statistical analysis.
- Bachelor’s degree in an Engineering subject area.
- 0-2 years experience for Associate Quality Engineer; 2+ years for Quality Engineer in combination device or medical device industry.
- Knowledge of combination device development process.
- Experience with device risk management activities.
- Quality mindset.
We have an inclusive and diverse culture that provides comprehensive benefits, which often include health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.
The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.
Salary Range (annually): $65,200.00 - $.
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