Quality Systems Specialist

Quality Systems Specialist role at Medtronic supporting medical device compliance across FDA and international regulatory frameworks. Responsibilities include leading investigations, maintaining quality systems, coordinating audits, and ensuring adherence to GMP and ISO standards for surgical operating units.

Responsibilities

• Lead investigations, root cause analyses, and corrective/preventive actions
• Provide quality system oversight and regulatory compliance guidance to ensure FDA and international adherence
• Coordinate internal and external audits aligned with regulatory standards
• Support EU surgical operating unit entities with quality oversight and compliance issue resolution
• Perform trend analyses and report compliance observations to identify improvement areas

Requirements

• Bachelor's degree in relevant field
• Minimum 4 years quality systems experience or advanced degree with 2 years experience
• Knowledge of FDA, GMP, QSR, ISO 13485, and MDSAP medical device regulations
• Proficiency with data analysis tools and problem-solving techniques
• Excellent written and oral communication skills
• Demonstrated leadership and independent decision-making ability
• Ability to manage multiple concurrent projects and priorities