Senior Quality Engineer, Medical Devices - Onsite

Real; California (MO); On-site; USD 120,000 - 160,000; Full time

Job summary

Specialist Staffing Group is seeking an experienced Senior Quality Engineer for an onsite role in Menlo Park, CA, to lead quality activities across development, transfer, and manufacturing readiness for a Class III medical device.

The candidate will partner with R&D, Operations, Clinical, and Regulatory Affairs, driving risk management per ISO 14971, DHF/DMR, V&V, and CAPA processes while ensuring compliance with FDA QSR 21 CFR 820 and ISO 13485.

Qualifications

• Bachelor's degree in Engineering or Life Sciences required.
• 8+ years medical device quality engineering experience with Bachelor's, or 6+ with Master's.
• Experience with ISO 14971 risk management, DHF/DMR, design controls.
• Knowledge of FDA QSR 21 CFR 820 and ISO 13485.

Responsibilities

• Serve as Quality representative on NPD teams, ensuring design controls, DHF, and documentation.
• Lead risk management activities per ISO 14971 including FMEAs and residual risk.
• Develop and execute V&V strategies with traceability and test method validation.
• Support design transfer and manufacturing readiness including DMR inputs and lot release.
• Review and approve validation protocols and reports (IQ/OQ/PQ, sterilization, packaging).
• Drive biocompatibility planning per ISO 10993 with cross-functional teams.
• Lead investigations of complaints, CAPA, deviations, and supplier quality issues.
• Assess ECOs for quality impact and ensure verification/validation.
• Support supplier qualification, audits, and incoming inspection.
• Analyze quality metrics and drive continuous improvement.
• Mentor team members and promote quality best practices.

Skills

Design controls

DHF/DMR documentation

Risk management

CAPA

NCR/NCMR

Supplier quality

Change control

FDA 21 CFR 820

ISO 13485

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in Engineering

Master's degree

Tools

Minitab

Job description

Specialist Staffing Group is seeking an experienced Senior Quality Engineer for an onsite role in Menlo Park, CA, to lead quality activities across development, transfer, and manufacturing readiness for a Class III medical device.

The candidate will partner with R&D, Operations, Clinical, and Regulatory Affairs, driving risk management per ISO 14971, DHF/DMR, V&V, and CAPA processes while ensuring compliance with FDA QSR 21 CFR 820 and ISO 13485.