Sr. Quality Engineer
Minnesota, Minneapolis-St. Paul-
Our client, a Global Medical Device Manufacture has an immediate opening for a Sr. Quality Engineer for a 6 Month + Contract. Our client offers results-driven people a place where they can make a difference every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
Position Description (Principle Duties and Responsibilities)
This operations quality engineer role is critical to continuing to build approximately $25, 000, 000 in COGS of ENT product annually for our clients customers. The tasks include clean room monitoring reports, daily product release, new product launches, NC and CAPA work, process validation, and many other business and quality system tasks. Losing this role risks delays to these critical tasks and potentially causing backorder and customer dissatisfaction.
Looking for candidates with at least 5 years or more of experience as a quality engineer in medical device.
Bachelor s degree in engineering field preferred
Must have the ability to work in a fast paced environment, take in new information and get up to speed quickly, work well in a team environment building good working relationships.
Top 3 Must-have skills:
1. Production quality experience provide quality engineering support for manufacturing including disposition of nonconforming material.
2. Quality system experience knowledgeable on medical device regulatory requirements, support internal and external audits, procedure updates.
3. Validation experience create, review, approve validation documents including IQ, OQ, PQ protocols and reports.
Top 3 desired skills:
1. Cleanroom experience familiarity with clean room qualification, ongoing monitoring, and test method validation protocols and reports. (all production takes place in a cleanroom)
2. Trackwise experience familiarity with NC-CAPA systems. (Trackwise is current system of use)
3. Risk management knowledge creating and maintain process FMEA, hazard analysis, risk management plans and reports per ISO 14971
The selected individual will need to hit the ground running. Our client will be handing tasks off to this individual as quickly as possible since the current engineer is overloaded.
The tasks for the first day might include working on clean room monitoring reports, daily product release, NC and CAPA work, process validation, and other business and quality system tasks.
This has the potential to turn into full time position.