Senior Quality Engineer – Regulatory & Process Excellence

Agendia; California; On-site; USD 120,000 - 160,000; Full time

Job summary

Agendia is seeking a QA/RA specialist to oversee quality engineering activities and ensure compliance with FDA/ISO requirements in product development and manufacturing.

You will drive continuous improvement across design control, risk management, supplier quality, and post-market surveillance, collaborating with Laboratory Operations, Product Development, and external regulators. Candidates should have a strong background in medical devices and regulatory affairs.

Qualifications

• Bachelor’s degree in a technical field; quality focus preferred.
• ASQ CQE or equivalent certification required; auditor certification preferred.
• Experience in regulatory affairs or quality management systems for medical devices.

Responsibilities

• Implement quality engineering tools to drive process development.
• Ensure compliance with FDA, ISO 13485, IVDR, and related standards.
• Lead investigations, CAPA, and continuous improvement.
• Participate in Design Control and Risk Management activities.
• Coordinate Post-Market Surveillance and supplier quality efforts.
• Manage quality agreements with vendors and verification protocols.
• Support audits and management reviews across functions.

Skills

Quality tools

Statistics

Sampling plans

Reliability engineering

Software engineering

Design assurance

Regulatory compliance

Process engineering

Education

Bachelor's Degree in Life Science/Engineering

ASQ CQE/Quality Engineer

ASQ Auditor or Lead Auditor

Tools

MS Office

Statistical software

Job description

Agendia is seeking a QA/RA specialist to oversee quality engineering activities and ensure compliance with FDA/ISO requirements in product development and manufacturing.

You will drive continuous improvement across design control, risk management, supplier quality, and post-market surveillance, collaborating with Laboratory Operations, Product Development, and external regulators. Candidates should have a strong background in medical devices and regulatory affairs.