Staff Quality Engineer - Medical Device NPI

Regulatory Jobs; Irvine (CA); On-site; USD 103,000 - 171,000; Full time

Job summary

Stryker is seeking a Staff Quality Engineer for New Product Introduction in Irvine, CA. You will lead quality engineering activities across design transfer, process validation, risk management, inspection strategy, supplier quality, and manufacturing readiness within a regulated environment.

You will apply PFMEA, MSA, and statistical methods to identify risks and drive improvements. You will also influence design for manufacturability, develop verification plans, and support PPAP activities to

Qualifications

• 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.
• 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, GMP, and GDP.
• Lean Six Sigma training and DMAIC experience.

Responsibilities

• Lead quality engineering activities for new product and process introductions with design transfer and regulatory alignment.
• Evaluate manufacturing risks using PFMEA and implement mitigation and control strategies per ISO 14971.
• Develop inspection strategies, sampling plans, FAI approaches, and MSA for scalable manufacturing.
• Develop and approve process validation strategies, protocols, reports, and data analyses.
• Apply statistical methods and structured problem-solving for process characterization and RCA.
• Support Design for Manufacturing by influencing process design, specs, inspection, tooling, and human-error controls.
• Lead supplier qualification, supplier validation, PPAP, supplier certification, and quality agreements.
• Represent Quality during design reviews and track launch-quality measures like right-first-time and product escapes.

Skills

PFMEA

Process Validation

MSA

Design for Manufacturing

Statistical Methods

Root-cause Investigation

Education

Bachelor of Science in Engineering or related discipline

Tools

Production Part Approval Process (PPAP)

Job description

Stryker is seeking a Staff Quality Engineer for New Product Introduction in Irvine, CA. You will lead quality engineering activities across design transfer, process validation, risk management, inspection strategy, supplier quality, and manufacturing readiness within a regulated environment.

You will apply PFMEA, MSA, and statistical methods to identify risks and drive improvements. You will also influence design for manufacturability, develop verification plans, and support PPAP activities to