NPI Quality Engineer (Onsite) – Process Validation

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

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.