Quality Engineer II (QMS Focus) - Medical

Description Quality Engineer II (QMS Focus) - Medical

Location: Irvine, CA (Onsite)

As a Quality Engineer II, you will be a key contributor to the implementation, maintenance, and continuous improvement of the Quality Management System (QMS). You will collaborate cross-functionally to ensure compliance with regulatory requirements, drive root cause investigations, and support quality initiatives that enhance product and process performance. Your role will be instrumental in ensuring that quality standards are embedded across the product lifecycle and that QMS processes are effectively executed and continuously improved.

Key Responsibilities

• Ensure compliance with internal QMS procedures and external regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820).
• Lead and support Nonconformance (NC) and Corrective and Preventive Action (CAPA) processes, ensuring timely closure and effectiveness verification.
• Collaborate with manufacturing, engineering, and supply chain teams to drive process improvements and reduce quality risks.
• Participate in internal audits and support external audits/inspections by regulatory bodies and notified bodies.
• Monitor and analyze quality metrics (KPIs), identify trends, and implement data-driven improvements.
• Support change control processes, ensuring quality impact assessments are conducted and documented.
• Manage complaint investigations and contribute to field action assessments and execution.
• Apply risk management principles (ISO 14971) throughout product and process development.
• Support validation activities (IQ/OQ/PQ) for equipment, processes, and software.
• Optimize inspection and sampling strategies using statistical techniques (e.g., SPC, DOE, Gage R&R).
• Promote Human Factors Engineering principles in product and process design.
• Contribute to training and awareness programs to reinforce QMS compliance and quality culture.

Essential Qualifications

• Proven experience in quality engineering within a regulated industry (medical device preferred).
• Strong knowledge of QMS standards and regulations (ISO 13485, FDA QSR, EU MDR).
• Proficiency in quality tools and methodologies: CAPA, FMEA, Root Cause Analysis, 8D, 5 Whys.
• Experience with document control, change management, and validation protocols.
• Familiarity with complaint handling, risk management, and audit readiness.
• Strong analytical, communication, and project management skills.
• Ability to work independently and collaboratively in cross-functional teams.

Preferred Qualifications

• Experience interacting with regulatory agencies (e.g., FDA, TUV, MoH).
• Working knowledge of electronic QMS platforms (e.g., MasterControl, TrackWise).
• Certification in quality (e.g., CQE, CQA, Six Sigma) is a plus.
• Strong computer literacy and data analysis skills.