Senior Quality Engineer (Design Assurance & QMS)

Compensation:

$120,000 - $150,000

Department:

Quality Assurance Reports to:

Director of QA Location:

Irvine, CA (Onsite) Position Summary The Senior Quality Engineer ensures end-to-end compliance with

FDA 21 CFR 820, ISO

13485, and international regulations across the full product lifecycle. This role bridges R&D design controls with downstream Quality Management System (QMS) requirements, providing quality oversight for new product development, risk management, post-market surveillance, and distribution logistics.

Key Responsibilities Design Assurance & R&D Support:

Serve as the lead Quality representative on core project teams. Drive design controls, risk management (ISO 14971), design reviews, test protocol/report approvals, and design verification and validation (V&V).

Early-Stage Development & Validation:

Support prototype testing, physician evaluations, packaging, shelf-life studies, sterilization validation, and test method validation (TMV). Quality Management Systems (QMS): Maintain and scale the QMS. Lead CAPA investigations, Non-Conformance Reports (NCR), root cause analyses, and audit readiness for internal and external regulatory inspections.

Commercialization & Distribution Quality:

Oversee quality controls related to warehousing, labeling, storage, distribution channels, and sales processes.

Post-Market Surveillance:

Lead customer complaint investigations, MDR reporting assessments, trend analyses, and post-market risk evaluations.

Manufacturing & Supplier Quality:

Qualify component suppliers, establish sampling plans, conduct process capability studies (Cpk​/Ppk​), and lead inspection method development.

Special Projects:

Support facility expansions, site relocations, and production line transfers. Required Qualifications Bachelor's degree in Biomedical, Mechanical, Materials/Metallurgical, or related Engineering discipline. 4+ years of medical device quality engineering experience spanning both Design Controls and QMS operations. Working mastery of FDA QSR (21 CFR Part 820), ISO 13485, ISO 14971, and EU MDR. Practical experience leading CAPA investigations, root cause methodology, and risk assessments (dFMEA/pFMEA). Strong foundation in applied engineering statistics (sampling plans, Gage R&R, ANOVA, process capability). Ability to work full-time onsite at the Irvine, CA facility.

Preferred Qualifications Professional certification:

ASQ CQE, CQA, CMQ/OE, or RAC. Direct experience with site transfers, facility relocations, or greenfield QMS implementation. Hands-on exposure to physician interactions in clinical, operating room, or wet-lab environments. Professional proficiency in Mandarin (verbal/written).

Pay:

$120,000.00 - $150,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Life insurance Paid time off Vision insurance

Work Location:

In person