Quality Assurance Manager

Yoh is hiring a Quality Assurance Manager for our medical device manufacturing client in the Los Angeles Metropolitan Area.

The Quality Assurance Manager will be responsible for overseeing the daily operations, maintenance, and continuous improvement of the company's Quality Management System (QMS).

In this role, you will be responsible for overseeing the daily operations, maintenance, and continuous improvement of the company's Quality Management System (QMS). The Quality Assurance Manager will ensure compliance with ISO 13485, FDA Quality Management System Regulation (QMSR), EU MDR, MDSAP, and applicable regulatory requirements while leading quality initiatives, supplier quality programs, audits, CAPA investigations, and continuous improvement efforts. The ideal candidate will have strong hands-on medical device quality experience, excellent leadership skills, and the ability to collaborate across Regulatory Affairs, Engineering, Operations, Supply Chain, and executive leadership.

Industry: Medical Device / Healthcare Products

Location: Los Angeles Metropolitan Area - Onsite

Compensation: $129,000–$145,000 annually (based upon experience)

Type: Direct Hire / Full-Time

Benefits: Medical, Dental, Vision, 401(k), Vacation

• Manage, maintain, and continuously improve the company's Quality Management System (QMS) in accordance with ISO 13485, FDA QMSR, EU MDR, MDSAP, and other applicable regulatory requirements.
• Oversee document control, change control, training records, nonconformances, deviations, and other core Quality System processes.
• Develop, review, and maintain SOPs, work instructions, quality procedures, and controlled documentation to ensure regulatory compliance.
• Lead internal, supplier, customer, Notified Body, MDSAP, and regulatory audits while maintaining continuous inspection readiness.
• Develop and execute risk-based internal audit schedules and coordinate audit preparation, execution, responses, and corrective actions.
• Serve as a key Quality representative during external audits and regulatory inspections, including FDA and Notified Body inspections.
• Lead the Corrective and Preventive Action (CAPA) program, including investigations, root cause analysis, corrective action implementation, and effectiveness verification.
• Monitor CAPA, nonconformance, and audit trends to identify systemic quality issues and implement sustainable improvements.
• Partner with Regulatory Affairs to support EU MDR compliance, technical documentation, post-market surveillance, risk management, and regulatory change assessments.
• Manage supplier quality activities, including supplier qualification, audits, monitoring, quality agreements, corrective actions, and performance evaluations.
• Evaluate supplier changes and quality events to determine potential impacts on product quality and regulatory compliance.
• Collaborate with Operations and Supply Chain to ensure appropriate controls are maintained for incoming products, materials, and components.
• Oversee or support receiving inspections, product testing, sampling, and material disposition activities.
• Support manufacturing, packaging, sterilization, and inspection process validation and qualification activities.
• Oversee product complaint handling and quality investigations, ensuring appropriate documentation, escalation, and resolution.
• Partner with Regulatory Affairs to support regulatory reporting and post-market surveillance requirements.
• Develop, monitor, and report Quality KPIs, including CAPA performance, complaints, supplier quality, audit findings, nonconformances, and training compliance.
• Analyze Quality System performance data and identify opportunities for corrective action and continuous improvement.
• Prepare Quality Management Review reports and…