Senior Quality Engineer - NPI (Onsite)
Summary
Senior Quality Engineer at Stryker’s Neurovascular division in Salt Lake City ensures medical device quality for new product launches, focusing on risk management, compliance, and validation testing.
Stryker is hiring a Senior Quality Engineer - New Product Introduction (NPI) to support our Neurovascular division. This is an onsite role based in Salt Lake City, UT.
As the Senior Quality Engineer - NPI, you will collaborate across functions to provide quality assurance support for all aspects of New Product Introductions, focusing on long-term strategies for Quality, Risk Management, Inspection & Testing, and Suppliers to ensure product competitiveness and compliance with domestic and international regulations.
Support risk management activities by maintaining Risk Management Files, conducting process FMEAs, implementing risk controls, and evaluating process risks throughout the product lifecycle.
Ensure compliance with ISO 14971 requirements and contribute to Critical-to-Quality identification, design risk assessments, and risk management documentation.
Develop and execute validation strategies, including Installation Qualification (IQ), Measurement System Analysis (MSA), Operational Qualification (OQ), and Performance Qualification (PQ).
Support Production Part Approval Process (PPAP), process validation, test method validation, and First Article Inspection activities for new product introduction projects.
Implement inspection and validation approaches that support scalable, compliant, and cost-effective manufacturing processes.
Apply statistical methods, process capability analysis, and quality engineering tools to strengthen process performance and support nonconformance and corrective action activities for new products.
Collaborate with suppliers by supporting qualification strategies, reviewing validation activities, and providing quality input for supplier selection, certification, and quality agreements.
Represent Quality Assurance during design transfer activities, monitor launch quality metrics such as right-first-time performance, inspection costs, and product escape rates, and provide post-launch quality support.
What You Need
Required
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
Preferred
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
- US5: $81,600 - $136,000 USD Annual