Senior Quality Engineer, New Product Introduction

Regulatory Toolkit; Irvine (CA); On-site; USD 89,000 - 149,000; Full time

Benefits offered by this job

Travel 20%

EOE employer

Job summary

Stryker is seeking a Senior Quality Engineer for New Product Introduction in Irvine, CA. You will support design transfer, risk management, validation, and supplier quality activities to ensure robust new products.

Responsibilities include developing inspection strategies, applying PFMEA and MSA, and collaborating across engineering, manufacturing and quality teams to deliver reliable medical devices.

Qualifications

• Bachelor’s degree in Engineering or 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.
• Experience with new product or new process introduction.
• CQE certification or equivalent quality engineering coursework or experience.
• Experience with medical device manufacturing and quality requirements, including ISO 13485, GMP, and GDP.

Responsibilities

• Support new product and process introductions by executing quality engineering activities through design transfer and product launch.
• Apply risk management principles to PFMEA, risk assessments, and process controls.
• Develop inspection strategies, sampling plans, and MSAs to support scalable manufacturing.
• Support validation protocols and reports, including sterilization validation where applicable.
• Apply statistical methods to evaluate process capability and drive corrective actions.
• Collaborate in design reviews and transfer activities to ensure quality deliverables.
• Execute supplier quality activities including PPAP, supplier qualification, and quality agreements.

Skills

Risk management

Quality engineering

Process validation

Statistical methods

Design transfer

Supplier quality

PFMEA

MSA

Education

Bachelor’s degree in Engineering

Tools

ISO 13485

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 that pay of other employees or applied …