Senior Quality Engineer — Medical Devices, CAPA & PPAP

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

Benefits offered by this job

Health benefits

401(k) plan

Employee stock purchase plan

Wellbeing program

Job summary

Stryker in Irvine, CA seeks a Senior Quality Engineer to support QA, QC, and continuous improvement across manufacturing operations, products, and processes. You will partner with cross-functional teams and suppliers to resolve quality issues, drive CAPA and nonconformance actions, and ensure regulatory compliance.

The role requires a Bachelor's in science or engineering and at least 2 years in quality engineering, with strong skills in risk management, auditing, statistics, and MSA.

Qualifications

• Bachelor's degree in science, engineering or related field.
• Minimum of 2 years of quality engineering experience with risk mgmt, CAPA, auditing and statistics.
• Experience applying risk management and compliance assessments in a regulated environment.
• Proficiency using Microsoft Office to analyze data and create reports.
• Experience developing/test method validations, protocols, and MSA (Gage R&R).
• Experience managing supplier quality activities and supplier performance.

Responsibilities

• Partner with Operations, suppliers, and cross-functional teams to drive quality performance and improvements.
• Own and support nonconformances, CAPAs, MRB activities, and product disposition.
• Collaborate with suppliers on corrective actions, supplier changes, PPAP, and part certification.
• Monitor and report quality metrics; apply statistical methods to identify trends and drive changes.
• Support manufacturing-related complaints, field actions, and regulatory compliance.
• Develop and improve quality system documentation, inspection methods, and sampling plans.
• Support validations/qualifications, MSA, engineering changes, and manufacturing transfers.
• Participate in internal/external audits and provide quality SME guidance.

Skills

Quality engineering

Risk management

CAPA

Auditing

Statistical methods

Data analysis

Supplier quality

Education

Bachelor's degree in science or engineering

Tools

Gage R&R

Job description

Stryker in Irvine, CA seeks a Senior Quality Engineer to support QA, QC, and continuous improvement across manufacturing operations, products, and processes. You will partner with cross-functional teams and suppliers to resolve quality issues, drive CAPA and nonconformance actions, and ensure regulatory compliance.

The role requires a Bachelor's in science or engineering and at least 2 years in quality engineering, with strong skills in risk management, auditing, statistics, and MSA.