Senior Quality Specialist

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

We are seeking an experienced Senior Quality Specialist / Quality Engineer to join a growing medical device organization in Foothill Ranch, CA.

This is a highly visible, hands-on Quality position for someone who enjoys working across multiple areas of the Quality Management System (QMS) rather than being limited to one specialized function.

The successful candidate will support Quality activities across Operations, Engineering, Customer Service, and Sales while helping maintain an effective and compliant Quality System.

Key Responsibilities

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

Qualifications

Required:

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

Preferred:

• Experience with Class II or Class III medical devices.
• ISO 13485 QMS auditor training/certification.
• Experience with CAPA, complaints, nonconforming material, supplier quality, audits, document control, DMR review, and Quality Management Review.
• Experience within orthopedic or spine medical devices is a plus.

Who We're Looking For

We're particularly interested in someone who is a well-rounded Quality professional and enjoys wearing multiple hats.

You may currently be working within a larger medical-device organization and looking for an opportunity where you can have greater ownership, visibility, and direct impact on the Quality System.

This role is well suited to someone who is hands-on, detail-oriented, collaborative, comfortable working cross-functionally, and capable of independently driving Quality activities.

• Full-time
• 100% onsite in Foothill Ranch, CA
• No annual bonus or equity currently
• Visa sponsorship is not available

Unfortunately, this position does not offer visa sponsorship or sponsorship transfers. Candidates must be U.S. Citizens or U.S. Permanent Residents (Green Card holders) to be considered.