Staff Quality Engineer, New Product Introduction

Staff Quality Engineer, New Product Introduction

Irvine, CA

 

Join Stryker’s Quality Engineering team supporting the development, transfer, and introduction of new medical devices, manufacturing processes, and technologies. In this role, you will provide technical quality leadership across design transfer, process validation, risk management, inspection strategy, supplier quality, and manufacturing readiness within a regulated environment.

 

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.
  

$102,700 - $171,100 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. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.