Summary:An opportunity is available for an experienced Quality Engineer to support quality systems, investigations, compliance, and continuous improvement within a regulated medical-device manufacturing environment.
Roles & Responsibilities: - Manage and investigate nonconforming materials, products and processes
- Support the complete CAPA lifecycle, including investigation, documentation and effectiveness activities
- Conduct structured Root Cause Analysis (RCA) and problem-solving
- Maintain compliance with established Quality Management System requirements
- Support compliance with ISO 13485 and FDA 21 CFR Part 820 / QMSR requirements
- Identify and implement quality and manufacturing process improvements
- Apply Lean Manufacturing and Six Sigma methodologies to reduce defects and improve operational performance
- Support inspection-ready documentation and quality records
- Collaborate with manufacturing, engineering and other cross-functional teams to resolve quality issues
Qualification: - Medical-device industry experience is mandatory
- CAPA and Nonconformance Management experience
- Quality investigations and Root Cause Analysis
- Strong Quality Management Systems knowledge
- ISO 13485 experience
- FDA QMSR / 21 CFR Part 820 knowledge
- Continuous improvement and process-improvement experience
- Lean Manufacturing / Six Sigma knowledge
- Experience working within highly regulated manufacturing environments
