Job Description:

Quality Field Corrective Actions Manager - Diabetes
Req Number: 210004N7
Northridge, CA or REMOTE within the US

Careers That Change Lives

In this exciting role as the Quality FCA Manager for the Diabetes Operating Unit, you will have responsibility for coordinating global field actions for Medtronic Diabetes. Our wide range of products include insulin pumps, glucose sensors, continuous glucose monitoring software and mobile applications, and therapy management software. Key responsibilities include developing global action plans for product related field actions, coordinating deployment of actions by cross functional US and global regional teams, and interaction with global regulators to respond to their inquiries.

Diabetes

The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. We're committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.

Visit www.medtronicdiabetes.com to see an overview of the products in our Diabetes product portfolio.

What does it take to be a leader at Medtronic? We look for inspiring and inclusive leaders who partner with others, knowing that diverse talent, skills, and perspectives lead to better outcomes.

A Day in the Life

• Leadership of global field actions, including coordination of planning, execution, and reporting via regular status updates and through authoring closure reports
• Manage resources to plan upcoming actions and track execution of ongoing actions
• Conduct global conference calls with regional counterparts to plan upcoming actions and remove any roadblocks as they emerge
• Serve as part of the enterprise FCA & PHO leadership team, partnering with broad enterprise functions as needed.
• Lead process improvement activities related to field actions and post-market surveillance
• Interface with other Medtronic Operating Units to understand and adopt best practices within Medtronic Diabetes

Responsibilities may also include the following and other duties may be assigned.

• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
• Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
• Co-ordinates legal requests in support of government investigations or litigations.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.

Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.

Bachelors degree with 5+ years of experience in Quality and/or regulated industry OR Advanced degree with 3+ years of experience in Quality and/or regulated industry.

Nice to Have

• Experience leading multiple functions through complex efforts on aggressive timelines
• Experience as functional manager with responsibilities for budget.
• Knowledge of and experience with CFR 21 Part 7, Enforcement Policy and ISO 13485:2016 Clause 7, Product Realization
• Excellent working knowledge of MS Excel, including pivot tables.
• Working knowledge of ISO 14971, Application of Risk Management to Medical Devices
• Experience developing processes that can be easily adopted globally
• Experience communicating directly with US and global regulatory agencies

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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 want to 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.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

Travel requirements for this role are up to 10%.

Additional Information

• Posting Date: Feb 18, 2021
• Travel: Yes, < 25 % of the Time

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