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Supplier Quality Program Manager

📁
Quality
📅
19000JQ2 Requisition #
Careers that Change Lives
In this exciting role as a Supplier Quality Program Manager, you’ll have the opportunity to lead Supplier Controls activities at the Mounds View facility as part of the CVG Supplier Quality team for both Internal & External Supplier Suppliers.  The role is primarily focused on the CRHF business where you’ll lead Mounds View Site Internal Supplier Controls deployment and execute deliverables such as creation of Internal Quality Agreements with Regions, Sites, and other Functions across Product & Service Suppliers.
 
You will also lead Internal Supplier Performance activities including monthly scorecard review, QBR execution with other MDT Groups/Regions, and escalation of trends/issues to Senior leadership when needed. You’ll provide input into the CVG internal audit process for audits of Mounds View’s internal suppliers and conduct ongoing reviews and oversight of key deliverables.  The role is responsible to provide front and back room support during Internal/External audits of the Mounds View facility in the area of Supplier Controls.
 
CVG
 

The Cardiac and Vascular Group brings all 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 

 
  • Creation of Quality Agreements, Risk Assessments and Supplier Selection records for existing & new MV Site suppliers

  • Quality Agreement Maintenance (periodic reviews)

  • Internal ASL establishment & ASL maintenance (Internal/External) for Mounds View Site

  • Internal Supplier Change Control oversight for Mounds View Suppliers

  • Review of Supplier Performance (Scorecards) and confirm Action Plans are documented at suppliers in response to poor performance

  • Confirm escalations for NC Trends to CAPA

  • Lead QBRs with non-CVG suppliers to Mounds View and provide data for QMRs

  • Lead Service Qualifications for suppliers to Mounds View

  • Internal Audit Planning Input

  • External Audit Support - Front/Back room support for Supplier Controls for Mounds View Site

  • Change Control coordination with Internal Suppliers


Responsibilities may 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 Requirement
To be considered for this role, please ensure the minimum requirements are evident on your resume.
 

Bachelor’s Degree in Engineering, Science or technical field with 5+ years of work experience in Engineering, Program Management and/or Quality OR Master’s Degree Engineering, Science or technical field with 3+ years of work experience in Engineering, Program Management and/or Quality.


Nice to Haves
•Experience with FDA requirements, ISO 13485, EU MDR, and/or Medical Device Directive or other regulatory requirements is an advantage.
•Audit experience with Backroom and Front room
•Strong communication skills
•Knowledge of Supplier Control Requirements
•Requires the ability to negotiate and manage competing priorities across multiple functional areas.
•Excellent analytical skills with the ability to define problems, collect data, establish facts, and draw valid conclusions
•Excellent organizational and time management skills required
•Strong computer skills, including MS Office Suite and database and project management software.
•Must be professional, dedicated, and detail-oriented. 



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% of the time.

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