Senior Quality Engineer

Real; San Mateo (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Real is seeking a Senior Quality Engineer to drive quality across design controls, risk management, V&V, design transfer, and supplier quality as we advance a Class III medical device through IDE.

We value hands-on collaboration with R&D, Operations, Clinical, and Regulatory teams to ensure regulatory success and manufacturing readiness on the path to commercialization.

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, verification and validation, design transfer, supplier quality, and CAPA investigations.
• Serve as a cross-functional partner to R&D, Operations, Clinical, and Regulatory teams, driving quality throughout development and commercialization.

Skills

Quality engineering

Design controls

Risk management

V&V activities

Regulatory compliance

CAPA

Supplier quality

Manufacturing readiness

FDA QSR

ISO 13485

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.

• 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.