Director Quality Management
About The Position
Director, Quality Management, serves as the site Quality Leader. This role is responsible for implementing, maintaining, and continuously improving the Quality Management Systems (QMS) to ensure full compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and cGMP requirements. The Director also ensures compliance of the Quality, complaints, validation, and manufacturing operations, and is accountable for coordinating site Management Review, internal audits, CAPA activities, Quality oversight of day-to-day production. This role partners with laboratory operations, Enterprise Quality and Regulatory, Legal Regulatory, Procurement, technology teams to support safe, compliant, and efficient design and development, and manufacturing of Medical Devices.
Responsibilities
- Implementing, maintaining, and continuously improving the Quality Management Systems (QMS)
- Ensuring full compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and cGMP requirements
- Ensuring compliance of the Quality, complaints, validation, and manufacturing operations
- Coordinating site Management Review, internal audits, CAPA activities, Quality oversight of day-to-day production
- Partnering with laboratory operations, Enterprise Quality and Regulatory, Legal Regulatory, Procurement, technology teams to support safe, compliant, and efficient design and development, and manufacturing of Medical Devices.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
No Education Listed
Number of Employees
5,001-10,000 employees
