Senior Quality Engineer, NPI & Process Validation - Onsite

Regulatory Jobs; 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

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.