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 LifeA Day in the Life:
- Owns and maintains periodic safety update reports (PSURs) by collaborating with Medical Safety, Regulatory and Clinical teams for all Aortic products
- Supports Clinical Evaluation Updates for all Aortic products
- Supports changes to released products in the field by being the quality reviewer on change orders
- Collaborates with cross functional teams like customer quality experience management, clinical affairs, medical safety, R&D, supplier quality, Manufacturing on a weekly basis to understand product complaints and assess field trends.
- Works closely with the customer quality experience management team, Returned Goods Investigation team and Manufacturing to understand product complaints received, update product codes and assist in investigations.
- Improve existing post market processes and systems to improve team performance and productivity
- Assists in root cause investigations for CAPAs and NCMRs related to product performance, health risk assessments, product holds, product testing and risk file updates as needed for product failure trends seen in the field
- Assists in conducting monthly trending of complaint data, evaluates negative trends, assesses risk to released products which aids in determining appropriate field actions and analyzes explants and returned products, as required.
- Prepare appropriate responses to regulatory queries for product registrations and other regulatory submissions by working with the regulatory affairs team and customer quality experience management team.
- Prioritize timely presentation of quality issues and escalate to leadership based on sound engineering, analysis & review for the success of the business.
- Supports internal and external audits
Key Skills & Experience
- Requires a bachelor’s degree and minimum of 2 years of relevant experience in Quality Engineering, Science OR master’s degree in engineering, Science, or technical discipline with a minimum of 0 years relevant experience
- Experience in a highly regulated industry, preferably medical devices
- Ability to work with cross functional groups to lead deliverables
- Work with cross functional groups to investigate technical problems and apply critical thinking
- Experience of working in complaint handling/post market quality team
Medtronic offer a competitive salary and flexible Benefits Package
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.
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.
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
