Quality Assurance Manager

Medical Device Manufacturing | California, USA

A growing medical device manufacturing company is seeking an experienced Quality Manager to lead and continuously improve its Quality Management System (QMS). This is a key leadership role supporting the manufacture of precision medical components used in critical healthcare applications.

The successful candidate will oversee quality assurance activities, regulatory compliance, supplier quality, audits, CAPA programs, and continuous improvement initiatives while partnering closely with Operations, Engineering, and Regulatory Affairs.

• Manage and maintain the company's Quality Management System in compliance with ISO 13485 and applicable FDA regulations.
• Lead internal, supplier, and external audits, including certification and customer audits.
• Drive CAPA, nonconformance, complaint handling, and root cause investigation processes.
• Ensure quality documentation, procedures, and records remain inspection-ready.
• Develop and monitor quality metrics, KPIs, and management review activities.
• Partner with manufacturing and engineering teams to improve product quality and process capability.
• Manage supplier qualification, supplier performance monitoring, and quality agreements.
• Support validation activities, process controls, and risk management initiatives.
• Lead training programs related to quality systems and regulatory compliance.
• Prepare for and support FDA inspections and customer quality assessments.
• Foster a culture of continuous improvement and operational excellence.

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical discipline.
• 5+ years of quality leadership experience within a regulated medical device manufacturing environment.
• Strong working knowledge of:
• ISO 13485
• FDA Quality System Regulations (21 CFR Part 820)
• CAPA
• Internal and external auditing
• Supplier Quality Management
• Validation and risk management principles
• Experience leading cross-functional quality improvement initiatives.
• Excellent communication and stakeholder management skills.

• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or similar certification.
• Experience with extrusion, catheter, tubing, polymer, or component manufacturing.
• Experience supporting FDA inspections and notified body audits.
• Familiarity with statistical process control and quality data analysis.

• Hands‑on leadership style.
• Strong problem‑solving and root cause analysis skills.
• Ability to influence across functions and drive accountability.
• Passion for building robust quality systems in a fast‑paced manufacturing environment.