Senior QA Engineer - Medical Devices (Remote)

Stryker; Irvine (CA); On-site; USD 103,000 - 171,000; Full time

Job summary

Stryker in Irvine, CA is seeking a Staff Quality Engineer in the Peripheral Vascular division to drive quality assurance, control, and continuous improvement across manufacturing operations, products, and processes.

You will partner with cross-functional teams and suppliers to resolve quality issues, lead CAPAs/NCs/MRB, and ensure compliant product disposition. The role requires ISO 13485 and 21 CFR 820 familiarity and a strong quality mindset.

Qualifications

• Bachelor's degree in a science, engineering or related discipline.
• Minimum of 4 years of quality engineering experience with demonstrated knowledge of quality system principles, including risk management, CAPA, auditing, and statistical methodologies.
• Preferred experience with supplier quality activities, ISO 13485 and 21 CFR Part 820 familiarity, GDP, GMP.

Responsibilities

• Drive product and process quality performance, resolve quality issues, and support continuous improvement initiatives.
• Own and support nonconformances (NCs), CAPAs, MRB activities, and product disposition with timely investigations and corrective actions.
• Collaborate with suppliers to address quality concerns, manage supplier corrective actions, evaluate supplier changes, perform PPAP activities, and support supplier part certification programs.
• Monitor, analyze, and report quality and process performance metrics using statistical methods, control charts, and risk management to identify trends and drive improvements.
• Support manufacturing-related complaints, field actions, commercial holds, and containment activities to ensure product quality and regulatory compliance.
• Develop, review, and improve quality system documentation, procedures, inspection methods, sampling plans, and Human Factors practices.

Skills

Quality engineering

Risk management

CAPA

Auditing

Statistics

Cross-functional

MS Office

Education

Bachelor's degree in science/engineering

CQE or CRE certification

Six Sigma Green/Black belt

Tools

Microsoft Office

Job description

Stryker in Irvine, CA is seeking a Staff Quality Engineer in the Peripheral Vascular division to drive quality assurance, control, and continuous improvement across manufacturing operations, products, and processes.

You will partner with cross-functional teams and suppliers to resolve quality issues, lead CAPAs/NCs/MRB, and ensure compliant product disposition. The role requires ISO 13485 and 21 CFR 820 familiarity and a strong quality mindset.