Staff Quality Engineer, New Product Introduction

What you will do

• Lead quality engineering activities for new product and process introductions, ensuring design transfer deliverables are completed, documented, and aligned with quality and regulatory requirements.
• Evaluate manufacturing and process risks using Process Failure Mode and Effects Analysis (PFMEA), identify mitigation and control strategies, and support risk management activities in accordance with ISO 14971.
• Develop inspection strategies, sampling plans, First Article Inspection approaches, and Measurement System Analysis (MSA) strategies that support repeatable, scalable, and efficient manufacturing.
• Develop and approve process validation strategies, protocols, reports, and data analyses to support capable, scalable manufacturing processes and high production yield.
• Apply statistical methods and structured problem-solving tools to process characterization, capability analysis, nonconformances, corrective and preventive actions, root-cause investigations, and process improvements.
• Support Design for Manufacturing and Assembly by influencing process design, production specifications, inspection optimization, tooling, fixtures, and human-error risk controls.
• Lead quality activities for supplier qualification, supplier validation, Production Part Approval Process (PPAP), supplier certification, and quality agreements.
• Represent Quality during design reviews and design transfer, tracking launch-quality measures including right-first-time performance, manufacturing loss, inspection cost, and product escapes.

What you will need

Required

• Bachelor of Science degree in Engineering or a related technical discipline.
• Minimum 4 years of experience in quality, engineering or technical discipline
• Experience in a regulated manufacturing environment.
• Experience with risk-based and statistical quality techniques, including FMEA, statistical sampling, process capability, and MSA.

Preferred

• Experience in new product or process introduction.
• Certified Quality Engineer (CQE) certification or equivalent quality engineering coursework or experience.
• Experience with medical device manufacturing and applicable quality requirements, including ISO 13485, Good Manufacturing Practices, and Good Documentation Practices.
• Lean Six Sigma training and experience applying structured problem-solving methods such as DMAIC.
• Experience with supplier qualification and supplier quality activities supporting new product introduction and manufacturing.