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Quality
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19000OKF Requisition #
Careers that Change Lives
In this exciting role as a Program Manager in the CVG Supplier Quality Group you will have responsibility to oversee and manage the execution of multiple programs supporting the implementation of the Internal Supplier controls process across all CVG Sites including realization of associated process efficiencies and IT solutions.

The role will require you to serve as a liaison between project teams and resolve issues by establishing priorities and reaching compromise with team members and functional managers across CVG.  You will have responsibility for review status of projects; management of schedules and preparation of status reports. 

Job responsibilities will focus on tactical needs for complex, on-going programs and accomplish results through matrixed teams. 
 
Collaboration with cross-functional resources to establish program objectives, timelines, and milestones will be key. 

CVG
The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.

A Day in the Life

- Manage the execution of Internal Supplier Controls project management activities / continuous improvement projects (e.g. project planning, tracking, risk management and communications with project core team leaders) and collaborate with team members representing the functions of Operations, Finance, Quality and Regulatory as necessary across all CVG sites. 
 - Develop effective project goals, work breakdown structures, responsibility matrices of the Internal Supplier Controls projects and schedules and interacts with project team members to drive completion of project objectives.

- Manage any required QMS Implementation.

- Identify costs and resource requirements for each program.
- Manage changing priorities on projects through effective schedule management. Keep Core Team Leader, Project Review Committee, key Sponsors and Stakeholders abreast of organizational capacity constraints and portfolio risks.

- Maintain current knowledge to ensure compliance to the FDA Quality System Regulations, European Requirements, and other regulatory requirements.

- Ensure Quality of all program and project outcomes, deliverables and products

- Comply with all Corporate policies, Standards, Procedures and Processes 
- Determines and pursues courses of action necessary to obtain desired results 
- Guides the architecture, governance, and measurement of the program. 
- Partners with management to lead quality initiatives that develop and maintain a high performing, scalable, and compliant Quality System. 
- Partners with Subject Matter Experts to drive development of clear objectives for education packages that improve competency. 
- Establishes meaningful metrics. 
- Consults on development of quality improvements and recommends alternatives. 
- Program management responsibilities may include planning, resourcing, providing status for, resolving issues, and identifying project risks for multiple work streams. 
- Ensures results meet requirements regarding technical quality, reliability, schedule, and cost.

 

Responsibilities may also include:

 

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.

Minimum Requirements
Bachelors Degree with 5+ years of experience in quality, operations, sourcing/supply management and/or program management or Advanced degree with 3+ years of quality, operations, sourcing/supply management and/or program management.
 
Nice to Have
•3+ years of project /program management strongly preferred.
•Experience with FDA requirements, ISO 13485 and Medical Device Directive or other regulatory requirements is an advantage.
•Demonstrated capacity for strategic thinking, project planning and project management.
•Strong communication, organizational, presentation and leadership skills are desirable.
•Excellent analytical skills with the ability to define problems, collect data, establish facts, and draw valid conclusions
•Excellent organizational and time management skills required.
•Successful track record of leading projects through implementation
•Strong computer skills, including MS Office Suite and database and project management software.
•Must be professional, dedicated, and detail-oriented. 
•Requires the ability to negotiate and manage competing priorities across multiple functional areas.
•Experience with FDA requirements, ISO 13485 and Medical Device Directive or other regulatory requirements is an advantage.

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 up to 10% Domestic and International

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