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Quality Engineer - Medical Device
Expansion position with a rising OEM medical device startup.
Excellent growth opportunity with visibility to Senior Leadership.
About Our Client
This company is a growing medical device start-up which has been rated one of the top manufacturing start-ups to work for. Located in the Billerica area, this organization manufacturers several catheter-based medical imaging devices and complementary products. They have reached their CE Mark and anticipate a 510K submission within the next few years.
- Monitor manufacturing of products, assuring compliance with DMR and assuring complete and correct Device History Records are maintained
- Perform/Participate in the Supplier Management & Internal Audit programs per schedule, and review the results of all audits to ensure resolution of any noted deviations.
- Participate in CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis. Coordinates implementation of corrective actions and preventive measures.
The Successful Applicant
- Bachelor's Degree with 3-5 years' medical device experience;
- Strong knowledge in the interpretation and application of relevant Domestic and International Quality System Regulations and Industry Standards (ISO 13485, 21 CFR 820, MDD, ISO 14971, IEC 60601)
What's on Offer
- Startup environment, wearing many hats and cross functional exposure
- Excellent benefits package
- Excellent base salary
- Growth opportunity