Quality Systems Engineer
About The Position
The Quality System Engineer is responsible for supporting the implementation, maintenance, and continuous improvement of the Quality Management System (QMS), with a primary focus on CAPA, Complaint Handling, Nonconformance Management, audit processes, and quality system infrastructure. This role ensures that QMS processes are effective, compliant, and aligned with applicable regulatory requirements, including FDA Quality Management System Regulation (21 CFR Part 820/QMSR), ISO 13485, and other global standards. The Quality System Engineer plays a critical role in driving consistent execution of quality system processes, improving process efficiency, and ensuring inspection readiness. This position partners cross-functionally to ensure quality system processes are well understood, effectively implemented, and capable of supporting product quality, patient safety, and regulatory compliance. This position is based in the Fremont, CA office.
Requirements
- Bachelor’s degree in engineering, science, or related discipline, or an equivalent combination of education and experience.
- 3–6 years of experience in Quality Assurance in the medical device field.
- Working knowledge of FDA 21 CFR Part 820/QMSR and ISO 13485.
- Strong experience with CAPA, complaints, nonconformance, and/or audits.
- Strong experience conducting/supporting investigations and root cause analysis.
- Strong analytical and problem-solving skills.
- Strong communication skills.
- Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
Nice To Haves
- CQI, CQE, CQA, or ISO 13485 Lead Auditor certification.
- Experience improving QMS processes.
- Experience with eQMS systems (e.g., Propel, MasterControl, Compliance Quest, Arena).
- Experience with medical robotics systems.
- Experience with metrics and data analysis.
Responsibilities
- Support the implementation, maintenance, and continuous improvement of core QMS processes.
- Ensure QMS processes align with FDA (21 CFR Part 820/QMSR), ISO 13485, and applicable standards.
- Maintain and improve procedures, work instructions, templates, and records.
- Drive consistency and integration across QMS processes.
- Support CAPA, complaint, and nonconformance processes.
- Perform and support investigations, including root cause analysis and VOE.
- Apply risk-based thinking for prioritization and escalation.
- Support internal audits and track findings.
- Support external audits and inspections.
- Ensure inspection-ready documentation in the eQMS.
- Develop and monitor quality metrics.
- Identify systemic issues and support continuous improvement.
- Collaborate cross-functionally to ensure compliance.
- Support training on QMS processes.
- Participate in management review preparation.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
