Quality Assurance Manager, Medical Devices – Onsite LA

Yoh Services LLC; Redondo Beach (CA); On-site; USD 129,000 - 145,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k)

Vacation

Job summary

Yoh is seeking a Quality Assurance Manager for a medical device client in the Los Angeles area. The role oversees the QMS, ensuring compliance with ISO 13485, FDA QMSR, EU MDR, and MDSAP while guiding audits, CAPA, and continuous improvement initiatives.

The candidate will collaborate with Regulatory Affairs, Engineering, Operations, and Supply Chain, driving risk-based decisions and ensuring inspection readiness across internal and external audits. Onsite, full-time, with competitive benefits.

Qualifications

• Bachelor's degree in a technical field and 5–7 years in quality assurance within regulated industries.
• Strong knowledge of ISO 13485 and FDA QMSR requirements.
• Experience leading CAPA, nonconformance, and internal audits.

Responsibilities

• Oversee the QMS to ensure ISO 13485, FDA QMSR, EU MDR, and MDSAP compliance.
• Lead audits with regulatory bodies, suppliers, Notified Bodies, and customers.
• Develop and implement CAPA investigations, root cause analyses, and corrective actions.
• Monitor quality metrics and drive continuous improvement across functions.
• Collaborate with Regulatory Affairs, Engineering, Operations, and Supply Chain.

Skills

Quality Assurance

Regulatory Compliance

Audits

CAPA

QMS

Leadership

Cross-Functional Collaboration

Education

Bachelor's degree in Engineering, Life Sciences, Quality, Biomedical Sciences, or related technical discipline

Tools

eQMS

Job description

Yoh is seeking a Quality Assurance Manager for a medical device client in the Los Angeles area. The role oversees the QMS, ensuring compliance with ISO 13485, FDA QMSR, EU MDR, and MDSAP while guiding audits, CAPA, and continuous improvement initiatives.

The candidate will collaborate with Regulatory Affairs, Engineering, Operations, and Supply Chain, driving risk-based decisions and ensuring inspection readiness across internal and external audits. Onsite, full-time, with competitive benefits.