Senior Medical Device Quality Engineer (QMS & CAPA)

BioTalent; Lake Forest (CA); On-site; USD 95,000 - 120,000; Full time

Job summary

BioTalent is seeking an experienced Senior Quality Specialist / Quality Engineer for a hands-on role in Foothill Ranch, CA. You will contribute across Operations, Engineering, Customer Service, and Sales to maintain a compliant Quality System.

This role emphasizes owning multiple quality responsibilities, supporting audits, CAPA, and continuous improvement within a small, fast-paced organization.

Qualifications

• 3+ years of quality experience in the medical device industry.
• Experience within a medical-device Quality Management System (QMS).
• Knowledge of ISO 13485 requirements.
• Experience with quality documentation and regulated processes.
• Proficiency with Microsoft Office.
• Ability to work in a small, fast-paced organization and take ownership across multiple quality responsibilities.

Responsibilities

• Route, release, and control Quality System documentation.
• Assign, monitor, and maintain training records.
• Maintain supplier qualification status and support supplier quality activities.
• Support the audit program, including supplier-related quality activities.
• Create, manage, and support CAPA (Corrective and Preventive Actions).
• Support and manage the complaint program.
• Lead investigations involving nonconforming material with proper segregation and documentation.
• Support Quality Management Review activities.
• Conduct Device Master Record (DMR) reviews for incoming and outgoing inspection.
• Develop and maintain Quality Plans.
• Work cross-functionally with Engineering, Operations, Customer Service, and Sales.
• Help maintain compliance with medical-device quality and regulatory requirements.

Skills

Quality experience

Microsoft Office

Cross-functional collaboration

Ownership mindset

Education

ISO 13485 auditor training/certification

Job description

BioTalent is seeking an experienced Senior Quality Specialist / Quality Engineer for a hands-on role in Foothill Ranch, CA. You will contribute across Operations, Engineering, Customer Service, and Sales to maintain a compliant Quality System.

This role emphasizes owning multiple quality responsibilities, supporting audits, CAPA, and continuous improvement within a small, fast-paced organization.