We anticipate the application window for this opening will close on - 30 Sep 2025

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Bring your talents to an industry leader in medical technology and healthcare solutions – we’re a market leader and growing every day. You can be proud to part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare. 

Join us for a career in IT that changes lives. 

 

Careers that Change Lives 

 

A Day in the Life 

 

POSITION RESPONSIBILITIES MAY INCLUDE THE FOLLOWING AND OTHER DUTIES MAY BE ASSIGNED: 

• Mastering knowledge of applicable Quality, FDA (Food & Drug Administration) Medical Device Directives/ Regulation, HIPPA (Healthcare Information Patient Privacy Act) and ISO (International Organization for Standardization) requirements through the updating of policies and procedures and acting as a liaison with appropriate policy experts.                                                                        

• Provides Quality System support and guidance to maintain compliance with all FDA and international regulatory requirements  

• Partnering with and influencing internal and external stakeholders to drive needed change and the execution of compliance program. 

• Responsible for communicating business related issues or opportunities to next management level 

• Coordination and/or preparation of internal and external audits in accordance with regulatory standards (includes FDA and its equivalents outside the US as well as other government regulatory agencies / authorities) for the Operating Unit 

• Owns and drives Investigations, Root Cause Analysis and resultant Corrective Actions and Preventive Actions 

• Perform trend analyses and report compliance observations to identify areas in need of improvement 

• Investigates and resolves compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc. 

• Excellent writing and editing skills, and computer skills. 

• Travel within US and International approximately 25% to off-site facilities to perform audits. 

 

 BASIC QUALIFICATIONS: 

 

MUST HAVE:  MINIMUM REQUIREMENTS: 

EDUCATION REQUIRED: 

• Bachelor’s Degree 

 

YEARS OF EXPERIENCE: 

• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience 

• Certified Lead Auditor from a recognized professional organization or an accrediting organization per a Quality Management System schema or standard. 

• Demonstrated knowledge of all quality system elements and regulatory requirements (i.e. FDA, GMP, QSR and ISO 13485, and MDSAP) for finished medical devices wi