Cardiac Ablation Solutions

The Cardiac Ablation Solutions (CAS) business is one of the fastest growing businesses and helps patients all over the globe requiring mapping and ablation for cardiac arrhythmias. The Cardiac Ablation Solutions Operating Unit focuses on Arrythmia disease management (including Atrial Fibrillation).

• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Participates in Quality System Integration activities and ensures integration is completed per plan.
• Coordinates modification records for management control.
• Establishes change orders and prepares for change authorization and documentation by company and subcontractor.
• Prepares reports of change effect on overall product.
• Ensures that customer requirements are implemented and reviews change accounting activity to ensure compliance with configuration management policies.
• Provide Quality System Integration reports and metrics and critical aspects regarding the health of the integration process.
• Supports the implementation of updates to the quality management systems aligned with integration activities.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Participates in audit inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.

• Bachelors degree required
• Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience

• Strong oral, presentation, and technical writing skills.
• Self-motivated, driven and committed to a team approach.
• Strong interpersonal, organizational and project management skills.
• Experience in medical device, pharmaceutical and/or a comparable regulated environment.
• Experience working with audit findings, corrections, and corrective actions.
• Quality System documentation systems (e.g. Agile) and issue management (e.g. Audit, CAPA) documentation systems experience (e.g. Trackwise).
• Experience with quality tools and process improvement techniques.
• Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques.
• Strong analytical and decision-making skills.
• Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and Medtronic quality requirements in general and specific to CAPA.

Ability to travel within the United States up to 25%.