Senior Quality Engineer - Medical Devices

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

Job summary

Stryker in Irvine, CA seeks a Senior Quality Engineer to provide QA/QC support across manufacturing operations, products and processes within Peripheral Vascular. You will lead CAPAs, MRBs and supplier actions while partnering with cross-functional teams to drive improvements and ensure regulatory compliance.

The role focuses on risk-based quality systems, process validation, and continuous improvement to enhance product quality and customer satisfaction.

Qualifications

• Minimum of 2 years of quality engineering experience with knowledge of quality system principles.
• Experience applying risk management principles and conducting compliance risk assessments in a regulated environment.
• Proficiency with data analysis, reporting, and cross-functional collaboration.
• Experience developing and executing test method validations and measurement system analyses.

Responsibilities

• Partner with Operations, suppliers, and cross-functional teams to drive quality performance and continuous improvement.
• Own nonconformances, CAPAs, MRB activities, and product disposition with timely investigations and corrective actions.
• Collaborate with suppliers on quality concerns, supplier changes, PPAP, and supplier part certification.
• Monitor and report quality metrics using statistical methods and risk management.
• Support manufacturing-related complaints, field actions, and regulatory compliance activities.
• Develop and improve quality system documentation, procedures, and sampling plans.
• Support validations/qualifications, MSA, engineering changes, and manufacturing transfers.
• Participate in audits and provide QA expertise to regulatory requirements.

Skills

Quality engineering

Risk management

CAPA

Auditing

Data analysis

Cross-functional collaboration

Education

Bachelor's degree in science/engineering

Tools

Microsoft Office

Gage R&R

PPAP

Job description

Stryker in Irvine, CA seeks a Senior Quality Engineer to provide QA/QC support across manufacturing operations, products and processes within Peripheral Vascular. You will lead CAPAs, MRBs and supplier actions while partnering with cross-functional teams to drive improvements and ensure regulatory compliance.

The role focuses on risk-based quality systems, process validation, and continuous improvement to enhance product quality and customer satisfaction.