Quality Manager - (US-MA-Natick - 01760)

Minimum Education: None
Jobcode: 56306249
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The Opportunity

Our client is an emerging medical device company developing innovative products that will provide surgeons with new methods to treat disorders of the spine and related orthopedic areas. This role will afford the right candidate the opportunity to build a growing company's ISO 13485 compliant Quality System and position the company for future success in regards to Quality Assurance compliance practices.

Job Responsibilities

In this autonomous role, you will champion the company's quality engineering and assurance efforts, establishing and maintaining a GMP compliant quality system and achieving current ISO 13485 certification. Additional core responsibilities include overseeing QA for product development teams, QSR implementation, CAPA management, Internal Auditing and Process Improvements as they relate to company wide quality systems.





Required Experience and Education

Candidates must have a BS degree in a technical discipline and 7+ years in medical device Quality Engineering and/or Quality Assurance. Extensive experience with the implementation of ISO 13485 compliant quailty systems is a must, as is significant quality engineering knowledge, as it relates to the development and launch of a new product.