Sr. Quality Assurance Manager
Twin Cities, Minnesota
A rapidly expanding genetic testing and diagnostics focused company is seeking a Sr. Quality Assurance Manager to join their rapidly expanding team. This is a newly created role and with a "hire from the top down" mentality you will have the opportunity to hire and shape a team below you in your own image. If you have a strong background in quality systems and are looking to expand your career into a cutting-edge area of the life sciences industries than don't hesitate to apply.
The Sr. Quality Assurance Manager will have the following responsibilities:
- Continue to develop the Quality System for the diagnostic lab and once the QMS is fully developed drive continuous improvement.
- Maintain the compliance of Quality Management System (QMS) to applicable requirements including CLIA/CAP/FDA.
- Works closely with cross-functional teams to ensure our suppliers, procedures, and services consistently meet specified requirements.
- Train junior staff cross functionally on QMS principals.
The ideal candidate will have the following skill set:
- Bachelor's degree.
- 5 years Quality Systems experience within the pharma or medical device industries.
- Familiarity with CLIA and CAP are helpful but not required.
- Experience with ISO 13485
- At least 1 year of management experience.