Duration
- 3-6 months
Job Description
- Our medical device client is currently seeking a Quality Engineer for quality-related functions pertaining to new production introduction (NPI’s), external manufacturing complaint analysis & investigations. There are upcoming product launches that are queued up for this year for a variety of medical devices such as catheters, electromechanical devices, ultrasonic medical devices, robotic medical devices and other related product types. There will be heavy cross-functional collaboration between various departments such as R&D, Regulatory Affairs, Quality, Lifecycle Management, Engineering Groups, Supply Chain and other related groups. Deliverables will consist of method validation, qualifications, device testing, IQ/OQ/PQ, writing protocols, nonconformance’s, CAPA’s, and other lab related work.
Candidates must have 10-15 years of proven experience with:
- Various product lines within medical devices within the quality space
Knowledge of entire product lifecycle from inception to product launches, NPI’s
Effective & efficient communication and a high sense of self accountability and professionalism regarding follow-ups while performing within a high-stress/high-volume environment.
Ability to take, learn and apply suggested feedback.
Experience with ETQ, Windchill and other related systems are a plus.
MN: Sr. Quality Engineer (235519)