Senior Quality Engineer, Product Introduction

Irvine, CA

Join Stryker’s Quality Engineering team supporting the introduction and transfer of new medical devices and manufacturing processes. In this role, you will provide quality engineering support across risk management, validation, inspection, supplier quality, and design transfer activities while partnering with Engineering, Manufacturing, Design Assurance, and Quality teams.

• Support new product and process introductions by executing and documenting quality engineering activities throughout design transfer and product launch.
• Apply risk management principles to process risk assessments, risk mitigation, process controls, and Process Failure Mode and Effects Analysis (PFMEA) in accordance with ISO 14971.
• Develop inspection strategies, sampling plans, First Article Inspection approaches, and Measurement System Analysis (MSA) strategies to support repeatable and scalable manufacturing processes.
• Support the development, execution, review, and approval of process validation protocols and reports, including sterilization validation activities when applicable.
• Apply statistical methods and quality engineering tools to evaluate process capability, identify risks, investigate nonconformances, and support corrective and preventive actions.
• Support Design for Manufacturing and Assembly through process design, inspection optimization, tooling and fixture development, and production specification development.
• Execute supplier quality activities, including supplier qualification, validation, Production Part Approval Process (PPAP), supplier certification, and Quality Agreements.
• Partner with cross-functional teams during design reviews and design transfer activities, documenting quality deliverables and transferring product and process knowledge to manufacturing and Quality Engineering teams.

• Bachelor’s degree in Engineering or a related technical discipline.

• Minimum 2 years of experience in quality, engineering or technical discipline
• Experience in a regulated manufacturing environment.
• Experience with risk management and process controls.

• Experience in new product or new process introduction.
• Certified Quality Engineer (CQE) certification or equivalent quality engineering coursework or experience.
• Experience with medical device manufacturing and quality requirements, including ISO 13485, Good Manufacturing Practices, and Good Documentation Practices.
• Lean Six Sigma training and experience with quality and statistical tools such as PFMEA, MSA, process capability, statistical sampling, and DMAIC.

• Experience with supplier qualification and supplier quality activities supporting new product introduction and manufacturing.

$89,400 - $148,900 USD Annual