Senior Quality Engineer – Medical Devices (Onsite, Irvine)

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

Job summary

Stryker Irvine, CA is seeking a Senior Quality Engineer in the Peripheral Vascular division to provide 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, audits, and nonconformances, and ensure compliance with ISO 13485, FDA 21 CFR 820, GDP, and GMP.

The role emphasizes data-driven decision making and QMS documentation.

Qualifications

• Bachelor's degree in science, engineering or related discipline.
• Minimum of 2 years of quality engineering experience with knowledge of risk management, CAPA, auditing, and statistics.
• Experience applying risk management principles and performing compliance risk assessments in regulated environments.
• Proficiency using MS Office to analyze data, create reports, and support cross-functional activities.
• Experience developing and executing test method validations and conducting Gage R&R analyses.
• Experience managing supplier quality activities, including supplier qualification and performance monitoring.

Responsibilities

• Partner with Operations, suppliers, and cross-functional teams to drive product and process quality and support continuous improvement.
• 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, and support supplier part certification programs.
• Monitor, analyze, and report quality and process metrics using statistical methods and risk management to identify trends and improvements.
• Support manufacturing-related complaints, field actions, holds, and containment to ensure regulatory compliance and product quality.
• Develop, review, and improve quality system documentation, procedures, sampling plans, and Human Factors practices.

Skills

Quality engineering

Risk management

CAPA

Auditing

Statistics

MS Office

Education

Bachelor's degree in science or engineering

CQE/CRE or Six Sigma Green/Black belt

Tools

Microsoft Office

Job description

Stryker Irvine, CA is seeking a Senior Quality Engineer in the Peripheral Vascular division to provide 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, audits, and nonconformances, and ensure compliance with ISO 13485, FDA 21 CFR 820, GDP, and GMP.

The role emphasizes data-driven decision making and QMS documentation.