Senior Quality Engineer

Medtronic seeks a Senior Quality Engineer in Santa Ana, California to lead post-market surveillance activities, complaint investigations, and quality system improvements for the Interventional Cardiology Therapies unit. The role requires on-site presence four days weekly and involves cross-functional collaboration with regulatory, clinical, and manufacturing teams.

Responsibilities

• Lead complex complaint investigations, root cause analyses, and product performance assessments for released products
• Drive complaint trending activities, identify quality signals, and assess patient and business risks
• Provide technical leadership in evaluating post-market surveillance data and field performance trends
• Collaborate with cross-functional teams to resolve complex quality issues and support regulatory submissions
• Develop and maintain regulatory deliverables including Periodic Safety Update Reports and post-market clinical follow-up activities

Requirements

• Bachelor's degree in engineering, health science, or technical discipline
• Minimum 4 years relevant experience, OR Master's degree with 2+ years experience, OR PhD
• Advanced degree in engineering or science preferred
• Experience with post-market surveillance, complaint handling, and risk management
• Knowledge of regulatory requirements for implantable medical devices
• Experience with statistical analysis, data trending, and signal detection
• Demonstrated leadership of cross-functional projects and process improvement