Staff Quality Engineer, New Product Introduction

Stryker Corporation; Irvine (CA); On-site; USD 103,000 - 171,000; Full time

Job summary

Stryker Corporation in Irvine, CA is seeking a Staff Quality Engineer to lead quality activities for new product introductions, design transfer, and regulatory compliance in a fast-paced, regulated environment.

You will drive PFMEA, validation strategies, inspection planning, and supplier qualification while ensuring right-first-time manufacturing and continuous improvement. 20% travel required.

Qualifications

• Bachelor degree in Engineering or related technical field.
• Minimum 4 years in quality, engineering or technical discipline.
• Experience in a regulated manufacturing environment.
• Knowledge of ISO 13485, GMP and GDP quality requirements.
• Lean Six Sigma training or DMAIC experience.

Responsibilities

• Lead quality activities for new product and process introductions.
• Develop PFMEA, risk mitigation and control strategies.
• Create inspection strategies, sampling plans and MSA approaches.
• Define and approve process validation strategies and reports.
• Apply statistical methods to CAPA, root-cause, and process improvements.
• Support design for manufacturing and supplier qualification activities.
• Represent Quality in design reviews and launch metrics.

Skills

Quality engineering

Risk management

FMEA

Statistical methods

Process validation

Education

Bachelor of Science in Engineering

Tools

CQE (Certified Quality Engineer)

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%

Equal Opportunity Employer

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. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility

• Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.
• Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.
• Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category.
• Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co‑located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.