QMS Engineer
Job Summary
The QMS Engineer is responsible for maintaining and improving the company's Quality Management System (QMS) to ensure compliance with ISO and regulatory standards. The role involves conducting quality audits, leading CAPA activities, and performing root cause analysis. Candidates will monitor key performance indicators to drive quality excellence across manufacturing operations.
Responsibilities
- Maintain and improve QMS compliance
- Conduct internal and external audits
- Lead CAPA and root cause analysis
- Monitor and analyze quality KPIs
Required Skills
- ISO standards proficiency
- Root cause analysis (8D, FMEA, 5 Why)
- Manufacturing quality management
- Leadership and communication
Job Details
Responsibilities:
- Maintain, implement, and continuously improve the company's Quality Management System (QMS).
- Ensure compliance with ISO standards, customer requirements, and applicable regulatory requirements.
- Develop, review, and maintain quality procedures, SOPs, work instructions, and quality documentation.
- Plan and conduct internal quality audits, identify non-conformities, and verify corrective actions.
- Coordinate external certification audits and customer quality audits.
- Lead Corrective and Preventive Action (CAPA) activities, including root cause analysis using quality tools such as 5 Why, Fishbone Diagram, 8D, FMEA, and PDCA.
- Monitor and analyze quality KPIs including Customer Complaints, First Pass Yield (FPY), Internal Reject Rate, COPQ, Supplier Quality Performance, Audit Findings, and CAPA Closure Rate.
Requirements:
- Bachelor's Degree in Engineering, Manufacturing, Industrial Engineering, Quality Management, or a related discipline.
- Minimum 3–5 years of experience in Quality Management Systems within a manufacturing environment.
- Hands-on experience in maintaining and improving ISO-certified management systems.
- Strong communication and interpersonal skills.
- Leadership and cross-functional collaboration.