Staff Quality Engineer, New Product Introduction

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

Work Flexibility: Onsite

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

Travel Percentage: 20%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.