JOB SUMMARYThe 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.
DUTIES & 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.
SUPERVISORY RESPONSIBILITIESQUALIFICATIONSRequired:- 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.
Preferred:- 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.
COMPETENCIES- Drive results
- Decision quality
- Attention to detail
- Riskbased thinking
- Process optimization
- Effective communication and collaboration
PHYSICAL DEMANDS & WORK ENVIRONMENT- Must be able to remain in a stationary position and operate office equipment for a prolonged period of time.
- Physical activities include, but not limited to constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs.
- Other infrequent physical activities include, but not limited to, positioning self to complete assigned tasks, and ascending/descending floors and/or ladders.
- Occasionally work around moving mechanical parts.
- Must be able to work in a schedule that commensurate with business operation, including work during weekends, holidays and/or times outside of normal business hours.
- Must be able to travel as business necessitates (up to 10%).
Disclaimer:The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be possible to enable individuals with disabilities to perform the essential functions.
