Quality Management System Manager
Job Summary
Leading the development and sustainability of the Quality Management System, the full-time remote Quality Management System Manager will harmonize quality procedures, analyze quality data for corporate reviews, and support supplier quality programs.
Key responsibilities
- Aid in developing and improving harmonized policies, procedures, and work instructions to meet business needs and comply with external requirements
- Establish reports to gather and analyze quality data for Corporate Management Review
- Support the Supplier Quality Program by classifying and qualifying suppliers, maintaining quality agreements, and managing Supplier Corrective Action Requests (SCAR)
Required qualifications
- Minimum bachelor's degree in life sciences, applied sciences, business, or a related field
- At least 5 years of industry experience, including 2 years of audit experience
- Knowledge of supplier quality systems, GCLP, and GMP requirements
- Familiarity with ISO13485, ISO15189 frameworks, and CAP/CLIA requirements
- Demonstrated experience interfacing with suppliers and aligning on quality agreements
Complete Job Description
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