Quality Engineering Manager

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 Manager, Quality Engineering is responsible for leading Quality Engineering activities throughout the product lifecycle - from design and development through manufacturing, verification, validation, clinical studies, and commercialization. This individual will partner cross-functionally to ensure products are designed, manufactured, and maintained in compliance with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971, and other applicable regulatory requirements.

This is a highly collaborative, hands‑on leadership role for an experienced quality engineering professional who enjoys solving complex technical challenges, building scalable quality systems, and helping bring innovative Class III implantable medical devices to market.

• Lead the Quality Engineering activities supporting product development, design transfer, manufacturing, supplier quality, and sustaining engineering activities.
• Partner with Engineering, Manufacturing, Clinical, Regulatory Affairs, and Operations to ensure quality is integrated throughout the product lifecycle.
• Serve as the Quality Engineering representative on cross‑functional product development teams from concept through commercialization.
• Lead Design Assurance activities including design reviews, design verification and validation, design transfer, and design change management.
• Ensure effective application of risk management principles in accordance with ISO 14971 throughout product development and post‑market activities.
• Review and approve engineering documentation including design history file (DHF), device master record (DMR), engineering change orders (ECOs), protocols, reports, specifications, and validation documentation.
• Drive process validation activities including IQ, OQ, PQ, software validation, equipment qualification, and manufacturing process validation.
• Lead root cause investigations using structured problem‑solving methodologies and ensure timely implementation of effective corrective and preventive actions (CAPA).
• Oversee nonconformance investigations, supplier quality issues, complaint investigations, and quality metrics to identify opportunities for continuous improvement.
• Partner with Supply Chain and Manufacturing to establish supplier quality requirements, supplier qualification processes, incoming inspection strategies, and supplier performance monitoring.
• Develop and monitor key quality metrics to evaluate product quality, manufacturing performance, and process capability.
• Support internal audits, supplier audits, management reviews, and regulatory inspections.
• Mentor and develop Quality Engineers while helping establish best practices and scalable quality engineering processes.
• Foster a culture of quality, continuous improvement, accountability, and operational excellence throughout the organization.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Manufacturing Engineering, or related technical discipline.
• 8+ years of Quality Engineering experience within the medical device industry.
• 2+ years of people leadership or technical leadership experience.
• Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and design control requirements.
• Demonstrated experience with Design Assurance, risk management, process validation, and manufacturing quality.
• Experience leading CAPAs, nonconformance investigations, root cause analysis, and continuous improvement initiatives.
• Familiarity with statistical methods and quality tools including SPC, process capability analysis, FMEA, Fishbone, 5 Whys, and DOE.
• Excellent communication, collaboration, and organizational skills.