Industry leading specialty medical products provider is seeking an experienced Senior Quality Engineer for a 6+ month contract assignment in Salt Lake City, UT. Candidate will help lead quality engineering activities for design, development, manufacturing and distribution of medical instruments to ensure a high level of process and product quality.
Responsibilities for the Quality Engineer
- Candidate will help lead quality engineering activities for design, development, manufacturing and distribution of medical devices to ensure a high level of process and product quality.
- Leads project teams coordinating the quality efforts of engineers, technicians and other professionals of various disciplines/departments to design, develop, and continuously improve medical device products
- Plans, schedules, conducts or coordinates detailed phases of the quality engineering work
- Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products
Requirements for the Quality Engineer
- Bachelor's Degree in Engineering or Science along with 3 + years of experience in medical device manufacturing or similar regulated environment
- Preferred industry experience include medical device, aviation, aerospace, automotive and defense
- Good knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment
- Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
- Demonstrated working knowledge to positively influence supplier quality performance
- Helpful: Internal Quality Auditor Qualification either in AS 9100 or ISO13485,CFR820 or comparable industry standards and regulatory requirements