Senior Quality Engineer - Katalyst Healthcares & Life Sciences
Wilmington, NC 28401
About the Job
Responsibilities:
- Develop and implement new machines/processes and improvements to existing methods, including risk analysis, qualification requirements, and validation activities.
- Support manufacturing through process improvements, statistical analysis, and project management.
- Lead validation efforts for new equipment and changes to existing systems.
- Provide support in defect analysis, risk management, and technical report writing.
- Collaborate with cross-functional teams, including Quality, Production, and corporate functions, to drive process improvements and ensure regulatory compliance.
- Participate in customer complaint evaluations, supplier assessments, and regulatory inspections.
- Support CAPA investigations, utilizing statistical tools and problem-solving methodologies to drive improvements.
- Maintain compliance with FDA 21CFR 210-211, 820, ISO 13485-2003, and other applicable standards.
- Bachelor's degree in engineering or related field, with at least 6 years of experience in a regulated manufacturing environment.
- Experience in quality systems, process validation, and CAPA investigations.
- Strong technical writing, statistical analysis, and project management skills.
- Familiarity with quality tools such as Six Sigma, ROI analysis, and risk management.
Source : Katalyst Healthcares & Life Sciences
