Lead Quality Engineer – Medical Device Combos

Regulatory Jobs; Foster City (CA); On-site; USD 158,000 - 204,000; Full time

Job summary

Regulatory Jobs is seeking a Lead Quality Engineer to drive quality for medical device combination product development in a fast-paced environment. You will lead design controls, risk management, and lifecycle quality oversight across programs and collaborate with Device Engineering on verification, validation, and tech transfer.

The role emphasizes regulatory compliance to FDA/ISO standards, with ongoing quality improvements, cross-functional communication, and key involvement with CMOs and

Qualifications

• Bachelor’s degree in Engineering or a scientific discipline with at least 8 years of relevant experience, OR Master’s degree with at least 6 years.
• Demonstrated experience in Quality Assurance for medical devices and/or drug-device combination products.
• Excellent verbal, written, and interpersonal communication skills, with the ability to influence across functions.
• Preferred: 10+ years supporting combination products with deep expertise in design controls and risk management.

Responsibilities

• Serve as a Lead Quality Engineer for medical device combination product development programs with a focus on design controls, risk management, and lifecycle quality oversight.
• Partner with Device Engineering on new development, supporting design verification, design validation, and technology transfer.
• Ensure compliance with regulatory standards including FDA 21 CFR Part 820, ISO 13485, ISO 14971 and related quality systems.
• Plan, implement, and track quality improvement initiatives with timely action on deliverables.
• Interface with cross-functional teams, CMOs, and suppliers to resolve complex quality issues for drug-device combinations.
• Act as escalation point for high-impact quality issues, risks, and decisions.
• Support strategic relationships with internal stakeholders and CMOs.
• Provide quality guidance for change controls, DHF, and RMF evaluations.
• Develop, review, and approve controlled documentation such as protocols, plans, reports, and risk analyses.

Skills

Lead Quality Engineer

Medical device development

Design controls

Risk management

Lifecycle quality

FDA compliance

Quality system

Design verification

Education

Bachelor’s degree in Engineering or a scientific discipline

Master’s degree in a related field

Tools

MSA

Gage R&R

FMEA

ISO 14971

Job description

Regulatory Jobs is seeking a Lead Quality Engineer to drive quality for medical device combination product development in a fast-paced environment. You will lead design controls, risk management, and lifecycle quality oversight across programs and collaborate with Device Engineering on verification, validation, and tech transfer.

The role emphasizes regulatory compliance to FDA/ISO standards, with ongoing quality improvements, cross-functional communication, and key involvement with CMOs and