Quality Engineer II – QMS Focus

Quality Engineer II – QMS Focus

We are seeking experienced Quality Engineers II with a strong focus on Quality Management Systems (QMS) to support the implementation, maintenance, and continuous improvement of our client's QMS in a regulated environment. This role is critical to ensuring compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant standards. Candidates should have experience driving CAPA, NC, and audit readiness, as well as cross-functional collaboration to drive quality improvements.

• Ensure QMS compliance with ISO 13485, FDA 21 CFR Part 820, and applicable regulatory requirements.
• Lead and support Nonconformance (NC) and Corrective and Preventive Action (CAPA) processes, including timely closure and effectiveness checks.
• Collaborate with manufacturing, engineering, and supply chain to improve processes and reduce quality risks.
• Support and participate in internal audits, and assist during external regulatory and notified body audits.
• Track and analyze quality metrics/KPIs, perform trend analysis, and implement corrective actions.
• Evaluate and support change control processes, including quality impact assessments.
• Conduct complaint investigations and support field action execution as needed.
• Apply risk management principles (per ISO 14971) across product and process development.
• Support validation activities (IQ/OQ/PQ) for equipment, software, and processes.
• Use statistical tools (SPC, DOE, Gage R&R) to optimize inspection and sampling strategies.
• Promote Human Factors Engineering (HFE) in design and process development.
• Deliver training sessions and awareness programs to enhance QMS compliance and quality culture.

• 3–6+ years of experience in Quality Engineering, preferably in the medical device or regulated industry.
• Strong understanding of QMS standards and regulations: ISO 13485, FDA QSR, EU MDR.
• Hands-on experience with quality tools: CAPA, FMEA, Root Cause Analysis, 8D, 5 Whys.
• Familiar with document control, change management, and validation protocols.
• Strong communication, problem-solving, and cross-functional collaboration skills.
• Ability to work independently and manage multiple quality initiatives simultaneously.

• Experience interacting with regulatory agencies (FDA, TUV, MoH, etc.).
• Experience with eQMS platforms such as Master Control or Track Wise.
• Certifications such as CQE, CQA, or Six Sigma.
• Proficient in data analysis, reporting, and common quality software tools.