Senior Quality Engineering Manager – Medical Devices

The Mullings Group; San Francisco (CA); On-site; USD 180,000 - 250,000; Full time

Job summary

The Mullings Group seeks a Manager, Quality Engineering to lead quality activities across the product lifecycle for implantable medical devices, ensuring compliance with FDA QSR (21 CFR Part 820), ISO 13485 and ISO 14971. This is a hands-on leadership role partnering across functions.

You will drive design assurance, risk management, CAPA, supplier quality, and process validation, mentor Quality Engineers, and foster a culture of quality and continuous improvement.

Qualifications

• 8+ years of Quality Engineering experience in the medical device industry.
• 2+ years of people or technical leadership.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971.
• Experience with CAPA and nonconformance investigations.
• Familiarity with SPC, FMEA, DOE, and quality tools.
• Excellent communication and collaboration skills.

Responsibilities

• Lead Quality Engineering activities across the product lifecycle, from design through commercialization.
• Partner with Engineering, Manufacturing, Regulatory, and Operations to embed quality throughout.
• Lead Design Assurance activities including design reviews, verification, validation, and transfer.
• Oversee CAPA, nonconformance investigations, and continuous improvement initiatives.
• Mentor Quality Engineers and establish scalable quality processes.

Skills

People leadership

Cross-functional collaboration

Communication

Problem solving

Education

Engineering degree

Tools

Quality management systems

Statistical methods

Job description

The Mullings Group seeks a Manager, Quality Engineering to lead quality activities across the product lifecycle for implantable medical devices, ensuring compliance with FDA QSR (21 CFR Part 820), ISO 13485 and ISO 14971. This is a hands-on leadership role partnering across functions.

You will drive design assurance, risk management, CAPA, supplier quality, and process validation, mentor Quality Engineers, and foster a culture of quality and continuous improvement.