Field Corrective Action/Recall Lead
Mounds View, Minnesota, United States
2 days ago
The Recall Leader is a project leader of cross-functional teams that successfully manages most aspects of the Field Corrective Action (FCA) process. The Field Action/Recall Leader is responsible for the planning and execution of Field Corrective Actions, Recalls or Advisory Notices by coordinating with different stakeholders and geographies. Among other responsibilities, the person in this role identifies and develops process improvements to increase effectiveness, efficiency and compliance.This position involves coordination with a diverse group of people in the following areas: legal, Sr. quality leadership, reliability engineers, supply chain, marketing, etc…
•Lead cross functional teams to facilitate the development, review and approval of global Field Corrective Action (FCA) Plans.
•Define recall strategy and actions that are compliant with all applicable regulations and internal procedures to properly address a product quality issue.
•Facilitate the development of FCA materials (letters, presentations, etc…) to effectively communicate relevant information to appropriate customers (e.g. health care providers, risk managers, hospital personnel, patients) and Medtronic field personnel to mitigate patient risks.
•Work with regulatory contacts to identify, plan and coordinate notifications to regulatory bodies and respond to regulatory and field inquiries in a timely fashion.
•Oversee the global execution of the global FCA plan to ensure adherence to plan actions and milestones.
•Assist in the response to regulatory inquiries related to Field Corrective Actions
•Maintain data and prepare reports, presentations, proposals and status updates for management.
•Performs other duties as assigned.
•Travel up to 10% of the time (domestic and international travel)
_I_ _N ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME_
Years of Experience
•4+ years of quality, compliance, or regulatory experience
•2+ years of experience with Medical Devices
•Project/Program management experience with ability of managing multiple projects simultaneously.
•Experience developing effective written communications and executive presentations
•Demonstrate sound judgment and critical thinking skills
•Energetic individual with ability to work under pressure and with tight deadlines
•Experience with FDA regulatory medical device requirements, 21CFR Part 806, Part 7; ISO 13485, Medical Device Directive.
•Experience improving process efficiencies using Lean Sigma tools
•Works independently under limited supervision
•General knowledge of Database Systems such as SAP, Siebel, Factory Works
•Proficient with MS office productivity tools
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life.We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We can accelerate and advance our ability to create meaningful innovations – but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.