Senior Quality Engineer - NPI (Onsite)

What You Will Do

• 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