Job Description
The Manager Quality Operations is responsible for leading and managing all aspects of Quality Operations, including Quality Control (QC) and Product Release, Supplier Quality Engineering (SQE), and oversight of Contract Manufacturing Organizations (CMOs) and key suppliers, including distributors. This role ensures that products are manufactured and released in full compliance with applicable quality and regulatory standards. The Manager Quality Operations leads a team of Quality Engineers and Quality Technicians, and holds the authority for product release.
Responsibilities
Quality Operations
- Oversee and manage day-to-day quality activities across internal operations and external manufacturing partners (CMOs).
- Ensure that all manufacturing and assembly activities, both internal and outsourced, are conducted in accordance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulations.
- Review and approve Device History Re...