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

Responsibilities may include the following and other duties may be assigned:

• Provide Quality System support and guidance to ensure compliance with Food and Drug Administration (FDA), international regulatory requirements, and applicable standards (e.g., ISO, HIPAA); maintain up-to-date policies and procedures in partnership with policy experts
• Support and maintain the Articulating Technologies Quality Management System (QMS), ensuring compliant implementation of processes related to General QMS, Design & Development, and Pilot Production
• Offer both proactive and reactive Quality Oversight to EU Surgical Operating Unit entities, including QMS setup, audit and certification support, and resolution of production quality issues, Product Hold Orders, and Field Corrective Actions
• Lead internal and external audit coordination in accordance with regulatory standards (FDA, international agencies), ensuring operational readiness and compliance across the Operating Unit
• Drive investigations, root cause analyses, and the implementation of corrective and preventive actions (Corrective and Preventive Actions) to address compliance problems, customer complaints, and regulatory issues
• Partner with internal and external stakeholders to influence and drive change, support compliance initiatives, and communicate business-related issues or opportunities to higher management
• Perform trend analyses and report compliance observations to identify continuous improvement opportunities; travel approximately 25% within the EU and internationally to support quality-related activities.

Required Knowledge and Experience:

• Bachelor’s Degree with a minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
• Demonstrated knowledge of all quality system elements and regulatory requirements (i.e. FDA, GMP, QSR and ISO 13485, and MDSAP) for finished medical devices with the ability to effectively implement and communicate those requirements in a government regulated healthcare industry, special focus on Core QMS, Design Control & Manufacturing processes/requirements
• Effective usage of data analysis tools, analytical and research skills, and problem-solving techniques with keen attention to detail and simultaneous understanding of the "big picture", desire to follow an audit trail to identify risks, non-conformances, true root cause, etc
• Outstanding written, oral communication, and presentation skills combined with sound judgement, ability to make decisions, work independently, demonstrated leadership skills
• Ability to manage and execute on multiple critical projects simultaneously. Capable to manage multiple priorities and escalate issues.

2 or more years relevant experience in a Design & Development  and/or Manufacturing setting and experience supporting and or participating in regulatory inspections and audits are considered advantages for this role.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here