A Day in the Life
• Facilitate the development, implementation, maintenance, training and continuous improvement of the Quality System.
• Assesses compliance and effectiveness of the Quality System with respect to relevant regulations, standards, and Corporate Policies. Where appropriate, work with other Medtronic business units to ensure compliance throughout. Where required, monitor change implementation plans.
• Leads and assists in preparation for and support of external regulatory and notified body audits including FDA, TuV, etc. and internal audits.
• Leads and assists in coordination of internal and external audit responses including FDA, TuV, and Corporate.
• Coordinates and maintains the Quality System certificates in document control storage system.
• Maintains Quality System Manufacturing Site Accreditation (MSA) procedure and point of contact with Medtronic Japan for Structural Heart sites within the Coronary and Structural Heart Business Unit.
• Supports implementation of quality objectives and plans to ensure that employees are involved in integrating quality into their processes to meet quality objectives.
• Completes tasks assigned in support of CVG Councils as requested. Accomplishes results through experienced exempt and non-exempt employees.
• Performs other related duties as assigned.
Must Have: Minimum Requirements
REQUIRED YEARS OF EXPERIENCE:
7 + years experience managing Quality Systems within medical device, pharmaceutical or manufacturing companies