Senior Quality Engineer, New Product Introduction

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

Job summary

Stryker Irvine, CA is seeking a Senior Quality Engineer for New Product Introduction to support the transfer of new medical devices and manufacturing processes. You will drive quality activities across risk management, validation, inspection, supplier quality, and design transfer in collaboration with Engineering, Manufacturing, Design Assurance, and Quality teams.

You will apply PFMEA, ISO 14971, process validation, and statistical methods to ensure robust product introductions and scalable

Qualifications

• 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.

Responsibilities

• 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 PFMEA under ISO 14971.
• Develop inspection strategies, sampling plans, First Article Inspection, and MSA strategies for scalable manufacturing.
• Support process validation protocols and reports, including sterilization validation when applicable.
• Apply statistical methods to evaluate process capability, investigate nonconformances, and support CAPA.
• Support Design for Manufacturing through process design, inspection optimization, tooling development, and production specs.
• Execute supplier quality activities including supplier qualification, PPAP, supplier certification and Quality Agreements.
• Partner with cross-functional teams during design reviews and design transfer activities, documenting quality deliverables.

Skills

Quality engineering

Risk management

Process controls

Statistical methods

Design transfer

Supplier quality

Validation

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

PFMEA

MSA

PPAP

Job description

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