Role Overview
The position offers a dynamic opportunity to lead and evolve a global audit program and the QMS process within the healthcare industry, ensuring compliance with ISO 13485 and GxP standards.
About Medtronic
Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year.
Key Responsibilities
- Support and document KPIs related to the monthly Audit/change control/QMS objectives.
- Provide mitigation, correction, and improvements plans in case of unaccomplished with the KPIs targets.
- Work hand in hand and directly with the operating groups and the Enterprise team to provide guidance, knowledge, and monitoring of all activities within the Audit/QMS processes.
- Coordinate cross-functional teams to ensure successful project execution.
- Provide guidance and experience in interpreting policies, regulations and procedures to ensure compliance.
- Support the process of self-inspections, internal and external audits, participate in the resolution of the findings to the applicable QMS.
- Lead and participate in projects within the Audit/QMS processes and Automation
Requirements & Eligibility
- Requires a bachelor’s degree in life science, engineering, or a related degree. (eg Pharmacy, Biomedical Engineering)
- Fluent in English
- Project management Skills.
- Lead or Internal Auditor certification in QMS. (eg ISO 13485 or GMP)
- 4+ years’ experience in a quality role in the health care industry with a high focus on ISO 13485 and/or GxP requirements.
Required Skills & Tech
ISO 13485GxPProject ManagementQMS