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
Medtronic is committed to improving how healthcare addresses the needs of more people, in more ways, and in more places around the world. As one company, we can accelerate meaningful innovation and we will only succeed with the right people on our team.
We are seeking an Associate Quality System Specialist to support the Center-Led organization with day-to-day activities. This role will provide support to stakeholders involved in Field Corrective Action (FCA) processes and will serve as the FCA conciliator. The position requires close collaboration with local quality representatives and commercial teams to ensure effective FCA execution in-country. Russian language proficiency is required.
Responsibilities may include the following and other duties may be assigned:
- Ensure full compliance with quality policies and procedures, supporting audits and operating within a regulated quality system.
- Coordinate and track all Field Corrective Action (FCA) activities, including translation, communication, and evidence consolidation (e.g., notification letters, reconciliation).
- Collaborate with cross-functional partners and QA SSC FCA specialist to drive timely execution and effectiveness checks of FCA tasks.
- Monitor accuracy and timeliness of recall data and reports, providing analytical support and updates to senior and corporate management.
- Maintain FCA documentation in the quality repository and follow up on missing or incomplete actions to ensure closure.
- Identify and implement process improvements to enhance compliance, efficiency, and collaboration across teams.
Required Knowledge and Experience:
- Bachelor’s degree in life sciences or a related field.
- Fluency in English and Russian.
- Ability to travel and work virtually with teams across the region.
- 1+ years of experience in quality systems, regulatory affairs, or administrative roles.
- Previous experience supporting quality system audits is a plus.
- Strong technical writing and documentation review skills is valued.
- Excellent critical thinking and analytical abilities.
Preferred skills include the ability to make independent compliance decisions based on regulations, relevant information, alternatives, and risk, along with a solid understanding of Medical Device Regulations and the Food and Drugs Acts applicable to the role. Experience in writing and reviewing technical documentation is highly valued, and familiarity with tools such as SAP, Smartsheet, Map Agile, and Power BI is considered an advantage.
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.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
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
