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Supplier Quality Engineering Manager

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Engineering
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18000NPN Requisition #
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Careers that Change Lives

In this exciting role as a Supplier Quality Engineering Manager you will have responsibility for providing leadership and direction to the Supplier Quality team for Cardiac Surgery & Structural Heart Businesses related to Contract Manufacturing & Original Equipment Manufacturers (OEMs). You will be the primary focal point for Supplier Controls systems and processes for both Products and Services and act as the point of contact for quality issues due to manufacturer performance issues. You will also Identify and lead quality improvement activities with the supply base using a risk-based approach and engage in Pre-Market Supplier Quality activities and influence engagement with Sourcing and Core Teams. In addition, you will promote active supplier partnerships with OEMs & Contract manufacturers to drive improvements to execute the Quality Strategy.


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

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

  • Lead Quality risk reduction programs with key OEM and Contract manufacturers.
  • Partner with key BU stakeholders, including Sourcing organization, to drive part quality and quality improvement efforts at OEMs and Contract manufacturers.
  • Lead Improvements to purchasing and supplier controls process including review and implementation of changes to associated systems and procedures ensuring full compliance to GMP standards required by the FDA, EU and other regulatory bodies.
  • Plan and execute Supplier Audits for surveillance & for cause audits where needed with the team across the supply base.
  • Manage the Supplier Quality annual operating plan & budget for OEM and Contract manufacturer areas of responsibility.
  • Develop goals and strategies for the Supplier Quality organization aligned with business plans and critical needs.
  • Support Business efforts that relate to the transfer of finished devices processes and test methods to OEM and/or Contract Manufacturers, ensuring that product and process is maintained in compliance to pre-determined requirements.
  • Support External OEM and CM validation activities for processes improvements.
  • Ensure implementation & oversight for supplier changes to verify all qualification and validation activities are meeting pre-defined Product and Process specifications, including review and approval with key stakeholders.
  • Lead Supplier Performance measurement and oversight including associated Performance Improvements actions related to OEMs and Contract manufacturers.
  • Drive Supplier CAPA activities based on feedback from supplier escapes, supplier audits, quality metrics, and customer complaints.
  • Support projects that may involve changes to processes/products currently in production, manufacturing transfers, label/IFU updates, sub-tier suppliers.
  • Plan & Lead Pre-Mkt Supplier Quality resources for engagement in new product development programs.  Partner with Quality Core Team Members from BU Quality to align on activities and timing.
  • Lead quality process improvements and streamlining activities.
  • Ensure Compliance to Supplier Controls across the supply base. 
  • Interface with internal and external auditors.  Manage any internal/external audits for front/back room associated with purchasing and supplier controls.
  • Participate on Enterprise or Group level Councils for QMS oversight & improvement.
  • Ensure timely completion of staff performance reviews and career planning. 


Must Have: Minimum Requirements
Nice to Have
  • Supplier Quality, Operations, or Sourcing experience
  • Use and understanding of Statistical Tools (Design of Experiments, Measurement System Analysis, Process Capability and Statistical Process Control)
  • Oral and written communication skills
  • Ability to work & lead a team and foster a partnership environment
  • Computer Skills (Microsoft- Word, Excel, Project, PowerPoint)
  • Project Management experience & Lean Sigma skill set
  • Quality System Lead Auditor experience (ISO 13485:2016)
  • Manufacturing & supplier controls experience in multiple areas
  • MS degree in science or engineering
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)

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