Senior Quality Engineer

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

We are partnering with a well-funded, clinical-stage medical device company that is advancing a breakthrough Class III technology through a pivotal IDE program and toward commercialization. This is an opportunity to join a growing team where quality is viewed as a strategic partner and plays a critical role in product development, manufacturing readiness, and regulatory success.

The Senior Quality Engineer will serve as a key cross-functional partner to R&D, Operations, Clinical, and Regulatory teams, owning quality activities across design controls, risk management, verification and validation, design transfer, supplier quality, and CAPA investigations. This is a highly visible role with the opportunity to make a significant impact on both the product and the organization as it scales.

Key qualifications include:

• 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

This role is ideal for someone who enjoys working in a hands-on environment, influencing cross-functional teams, and helping bring innovative medical technologies from development through commercialization.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.