Staff Quality Assurance Engineer

Stryker • Irvine, CA

9d • Onsite

About The Position

Stryker is hiring a Staff Quality Engineer for its Peripheral Vascular division in Irvine, California. The role provides Quality Engineering support for quality assurance, quality control, and continuous improvement activities across manufacturing operations, products, and processes. The engineer partners with cross-functional teams and suppliers to resolve quality issues, drive corrective and preventive actions, and improve quality performance. The role leads and supports initiatives to improve product quality, operational efficiency, and customer satisfaction while ensuring compliance with applicable regulatory requirements, industry standards, and quality system expectations.

Requirements

• Bachelor's degree in a science, engineering, or related discipline.
• At least 4 years of quality engineering experience.
• Demonstrated knowledge of quality system principles, including risk management, CAPA, auditing, and statistical methodologies.
• Experience applying risk management principles and conducting compliance risk assessments in a regulated environment.
• Proficiency with Microsoft Office tools for data analysis, report creation, and cross-functional business support.

Nice To Haves

• Experience managing supplier quality activities, including supplier qualification, performance monitoring, and quality issue resolution.
• CQE or CRE certification and Six Sigma Green Belt or Black Belt.
• Medical device industry experience and knowledge of U.S. and international medical device regulations, including familiarity with ISO 13485, 21 CFR Part 820, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP).
• Experience with regulatory inspections and audits, including direct interaction with agencies such as FDA, TUV, and MoH.

Responsibilities

• Partner with Operations, suppliers, and cross-functional teams to improve product and process quality, resolve quality issues, and support continuous improvement.
• Own and support nonconformances, CAPAs, MRB activities, and product disposition, ensuring timely investigation, root cause analysis, corrective actions, and closure within quality systems.
• Work 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; use statistical methods, process controls, and risk management principles to identify trends and drive improvements.
• Support manufacturing-related complaints, field actions, commercial holds, and containment activities to maintain product quality and regulatory compliance.
• Develop, review, and improve quality system documentation, procedures, inspection methods, sampling plans, and Human Factors practices.
• Support process, equipment, and supplier validations and qualifications; measurement system analysis (MSA); engineering and supplier-initiated changes; and manufacturing transfer activities.
• Participate in internal and external audits and provide quality subject matter expertise to support compliance with quality system and regulatory requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior