Senior Quality Engineer - MedTech, Design Controls

Real Staffing; San Mateo (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Job summary

Real Staffing partners with a well-funded medical device company advancing a Class III technology through an IDE program toward commercialization. The Senior Quality Engineer will partner with R&D, Operations, Clinical and Regulatory teams, owning quality activities across design controls, risk management, V&V, design transfer, supplier quality and CAPA.

This hands-on, cross-functional role offers visibility and the chance to shape quality processes as the company scales.

Qualifications

• 6+ years of medical device quality engineering experience.
• Strong knowledge of design controls, DHF/DMR documentation, and ISO 14971 risk management.
• Experience leading V&V activities, requirements traceability, and validation efforts.
• Working knowledge of ISO 13485 and FDA Quality System Regulations.
• Experience with CAPA, NCR/NCMR, change control, supplier quality, and manufacturing readiness.
• Prior Class III, IDE/PMA, implantable device, or startup experience is highly desirable.

Responsibilities

• Own quality activities across design controls, risk management, V&V, design transfer, supplier quality, and CAPA investigations.
• Partner with R&D, Operations, Clinical, and Regulatory teams to scale development to commercialization.
• Lead quality improvements to support IDE/PMA filings and regulatory success.

Skills

Design controls

DHF/DMR documentation

ISO 14971 risk management

V&V activities

Requirements traceability

CAPA & NCR/NCMR

Manufacturing readiness

Job description

Real Staffing partners with a well-funded medical device company advancing a Class III technology through an IDE program toward commercialization. The Senior Quality Engineer will partner with R&D, Operations, Clinical and Regulatory teams, owning quality activities across design controls, risk management, V&V, design transfer, supplier quality and CAPA.

This hands-on, cross-functional role offers visibility and the chance to shape quality processes as the company scales.