Senior Quality Engineer - NPI (Onsite)

About the role

This is an onsite role based in Salt Lake City, UT. The Senior Quality Engineer - NPI collaborates 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.

Responsibilities

• 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 IQ, MSA, OQ, and 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.

Requirements

• 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

Qualifications

• US5: $81,600 - $136,000 USD Annual
• Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
• Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.