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Quality
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19000659 Requisition #
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Careers that Change Lives


A Day in the Life

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


  • Daily Policy Deployment Tier meetings and Gemba walks

  • Communication with Global Quality and peers (Alignment of the site to the Business Unit/ Corporate Requirements)

  • Internal Customer Relations

  • External Customer Relations

  • Attendance and engagement with site leadership.

  • Oversight and engagement with manufacturing personnel.

  • Inspection and Quality Release oversight

  • CAPA Management

  • Engagement and management of site Quality Improvement Plan.

  • Engagement on plant strategic objectives as prioritized

  • Quality Begins with Me Program (Model Behavior)

  • “Part Transfers” Quality Project

  • Hiring and team building to create a World Class Quality Organization

  • Department Cost Center and Finance Reviews

  • Preparation for, and participation in QSR, MOR, Monthly Staff Meeting, etc

  • Site communications participation (Department, Plant, Safety, Quality, etc)

  • Preparation and participation of Data analysis and Management Reviews, including use of appropriate statistical techniques.

  • Participation and engagement in Cost Down projects

  • Accountable for handling/ Disposition of Non-conforming Products

  • Accountable for establish quality system initiatives for ensuring compliance to regulatory requirements

  • Participation and engagement in PMO/ Continuous improvement projects and activities

  • Audit/ Regulatory Inspection leadership

  • Inputs and approvals as needed for Quality System components (Agile, Trackwise, Change Control, etc)

  • Support validation activities as required


Must Have: Minimum Requirement

 

  • Mid to Large Manufacturing facility on site quality leadership experience
  • A four-year college degree in one of the engineering disciplines or a related field with 5 plus years of direct experience.  
  • 3+ years of progressive leadership experience in functional area or related field
  • Knowledge and application of industry standards and regulatory requirements (including but not limited to: ISO 13485, ISO 14971, MDD 93/42 EEC, PMDA, CMDR, RDC 59, TGA, and 21 CFR Part 820).
  • Demonstrated track record of Regulatory­ Inspection management.
  • Experience implementing systems that drive compliance with all requirements.
  • Extensive experience with successful hiring and team building

Nice to Have

 

  • CNC or automated machining environment experience
  • Experience manufacturing finished medical devices
  • Medical Device cleaning validation and management experience
  • Cleanroom processing and packaging experience
  • Advanced degree (e.g., MBA).
  • Quality certification (CQM or CQE or equivalent).

 

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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Change Begins With You

We look for bold ideas and fresh insights - that's what drives innovation. Come drive the future of healthcare with us.

Engineering

The opportunity to invent. The benefit of joining a leader. The power to improve lives. You’ll find all that and more here.

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Join us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world.

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Alyse is an Engineering Program Manager for Neuromodulation in Minneapolis, Minnesota.

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

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MEDTRONIC

Be part of one of the world’s leading medical technologies and solutions companies.