: As a Quality Engineer for New Product Introduction (NPI) at Stryker, you will provide technical leadership for quality assurance and control activities throughout the product lifecycle. You will lead initiatives related to risk management (pFMEA), process validation, supplier qualification, and inspection strategy design, ensuring regulatory compliance and successful product launches.

Responsibilities: Support new product design and transfer with strong cross-functional collaboration. Develop and optimize inspection strategies using lean methods. Lead or support CAPAs, validations (IQ/OQ/PQ), risk analysis, and PFMEA. Coordinate with suppliers to ensure quality in materials and documentation (, PPAP). Maintain and review design history files (DHF) and risk management documentation per ISO . Serve as a Quality lead during Design Transfer Agreement Planning (DTAP) Represent QA in regulatory audits. Requirements: Bachelor's in engineering or related field. – years in a quality engineering or related technical role, Experience with ISO standards, PFMEA, NPI, Design Transfer, Risk Management, and Validation. Knowledge in CQA, CTQ, ISO , MSA, and manufacturing process controls. Strong production documentation overhaul experience (, MVPs, value stream mapping). Hands-on with medical device validation and design control.