This candidate will be responsible for the development, implementation, maintenance, and improvement of quality assurance processes. Throughout the implementation and maintenance process, this candidate should use data analysis to better understand quality reporting measures and improve processes.
- Maintain and improve the QMS to ISO:13485 standards, initiating CAPAs, NCRS, audits, training etc.
- Support operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams.
- Provide direction in implementing and continuously improving Incoming Inspection, First Article Inspection, In-Process and Final Product Inspection plans.
- Bachelor's degree or equivalent in Mechanical, Electrical, or Manufacturing Engineering
- 2+ years' of Quality Engineering experience in a Medical Device manufacturing environment.
- Analytical and quantitative approach to problem solving