What are the responsibilities and job description for the Quality Assurance Manager position at BioTalent?
Quality Assurance Manager – Medical Device
Location : San Jose Bay Area (Fully Onsite)
Industry : Medical Device - Class III
About the Company
Join a cutting-edge medical device company in the San Francisco Bay Area focused on developing innovative healthcare solutions. We are seeking a Quality Assurance Manager to lead and enhance our quality systems, ensuring compliance with FDA, ISO 13485, and EU MDR regulations. This is an exciting opportunity to be a key player in a fast-paced, collaborative environment dedicated to advancing patient care.
Position Summary
The Quality Assurance Manager will be responsible for overseeing design control activities and ensuring compliance with EU MDR and FDA regulations . This role requires a hands-on leader who can work cross-functionally with R&D, Regulatory Affairs, and Manufacturing teams to maintain high-quality standards and drive continuous improvement in product development processes.
Key Responsibilities
- Lead design control activities throughout the product development lifecycle, ensuring compliance with 21 CFR Part 820, ISO 13485, and EU MDR .
- Manage and maintain quality system documentation related to design history files (DHF), risk management files, and technical documentation for regulatory submissions.
- Support EU MDR transition efforts , including gap assessments, remediation plans, and compliance with General Safety and Performance Requirements (GSPR) .
- Oversee risk management activities in accordance with ISO 14971 , ensuring risk assessments are conducted and documented properly.
- Collaborate with R&D and Regulatory teams to ensure design verification and validation (V&V) activities meet regulatory expectations.
- Lead and support internal and external audits , including FDA inspections, Notified Body audits, and supplier audits.
- Drive continuous improvement initiatives within the quality management system (QMS) to enhance efficiency and compliance.
- Provide quality training to cross-functional teams on design controls, risk management, and regulatory requirements .
Qualifications & Experience
Preferred Qualifications
