Senior Quality Engineer - NPI (Onsite)
$81,600–$136,000 year
On-siteSalt Lake City, Utah, United States
Job Summary
Support risk management activities by maintaining Risk Management Files, conducting process FMEAs, and implementing risk controls throughout the product lifecycle. Develop and execute validation strategies including IQ, MSA, OQ, and PQ while supporting Production Part Approval Process (PPAP) and First Article Inspection activities. Apply statistical methods and quality engineering tools to strengthen process performance and manage nonconformance corrective actions. Collaborate with suppliers on qualification strategies and represent Quality Assurance during design transfer activities to monitor launch quality metrics. This onsite role in Salt Lake City requires a Bachelor's degree in Engineering and minimum two years of experience in the medical device industry.
Required Qualifications
- Bachelor's degree in Engineering, Science, or a related technical field
- Minimum 2 years of full-time work experience in Quality Assurance, Quality Engineering, Design Transfer, Manufacturing Engineering, or related functions within the medical device industry
- Minimum 2 years of full-time work experience in a regulated industry environment
- 20% travel
- Onsite location in Salt Lake City, UT
Desired Qualifications
- Minimum 2 years of experience in an engineering role within the medical device industry
- ASQ Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) certification
- Experience working with ISO 13485 and ISO 14971 standards
- Experience with process validation, test method validation, FMEA, statistical analysis, process capability studies, and Measurement System Analysis (MSA)
- Experience applying Lean Six Sigma DMAIC methodologies to process improvement initiatives
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