Senior Quality Engineer, New Product Introduction

Stryker Corporation; Irvine (CA); On-site; USD 89,000 - 149,000; Full time

Job summary

Stryker Corporation is seeking a Senior Quality Engineer for New Product Introduction in Irvine, CA. You will support risk management, validation, supplier quality, and design transfer across cross-functional teams.

The role emphasizes applying PFMEA, MSA, process validation, and statistical methods to ensure robust manufacturing for medical devices. Travel ~20% and onsite work at Stryker facilities.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• Minimum 2 years in quality, engineering, or technical discipline.
• Experience in regulated manufacturing environments.
• Experience with risk management and process controls.
• CQE certification or equivalent quality coursework/experience.
• Experience with medical device manufacturing and ISO 13485.

Responsibilities

• Support new product and process introductions through design transfer and product launches.
• Apply risk management principles to PFMEA and process controls.
• Develop inspection strategies, sampling plans, and MSA methods.
• Support process validation protocols and reports, including sterilization when applicable.
• Apply statistical methods to evaluate process capability and investigate nonconformances.
• Collaborate with cross-functional teams during design reviews and design transfer.

Skills

CQE certification

Quality engineering

Risk management

Statistical methods

Education

Bachelor's degree in Engineering

Tools

PFMEA

MSA

PPAP

Process validation

Job description

Work Flexibility: Onsite Senior Quality Engineer, New Product Introduction Irvine, CA

Join Stryker's Quality Engineering team supporting the introduction and transfer of new medical devices and manufacturing processes. In this role, you will provide quality engineering support across risk management, validation, inspection, supplier quality, and design transfer activities while partnering with Engineering, Manufacturing, Design Assurance, and Quality teams.

What you will do

• Support new product and process introductions by executing and documenting quality engineering activities throughout design transfer and product launch.
• Apply risk management principles to process risk assessments, risk mitigation, process controls, and Process Failure Mode and Effects Analysis (PFMEA) in accordance with ISO 14971.
• Develop inspection strategies, sampling plans, First Article Inspection approaches, and Measurement System Analysis (MSA) strategies to support repeatable and scalable manufacturing processes.
• Support the development, execution, review, and approval of process validation protocols and reports, including sterilization validation activities when applicable.
• Apply statistical methods and quality engineering tools to evaluate process capability, identify risks, investigate nonconformances, and support corrective and preventive actions.
• Support Design for Manufacturing and Assembly through process design, inspection optimization, tooling and fixture development, and production specification development.
• Execute supplier quality activities, including supplier qualification, validation, Production Part Approval Process (PPAP), supplier certification, and Quality Agreements.
• Partner with cross-functional teams during design reviews and design transfer activities, documenting quality deliverables and transferring product and process knowledge to manufacturing and Quality Engineering teams.

What you will need

• Required Bachelor's degree in Engineering or a related technical discipline.
• Minimum 2 years of experience in quality, engineering or technical discipline.
• Experience in a regulated manufacturing environment.
• Experience with risk management and process controls.
• Preferred Experience in new product or new process introduction.
• Certified Quality Engineer (CQE) certification or equivalent quality engineering coursework or experience.
• Experience with medical device manufacturing and quality requirements, including ISO 13485, Good Manufacturing Practices, and Good Documentation Practices.
• Lean Six Sigma training and experience with quality and statistical tools such as PFMEA, MSA, process capability, statistical sampling, and DMAIC.
• Experience with supplier qualification and supplier quality activities supporting new product introduction and manufacturing.

$89,400 - $148,900 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. 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.

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.
• 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.