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Quality Assurance Program Manager

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Quality
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19000K5U Requisition #
Careers that Change Lives
In this exciting role as a Quality Assurance Program Manager you will have responsibility for the quality function on product development programs in the Aortic Business Unit. The Quality Core Team Member will represent the Quality Function in all discussions and decisions on the Core Team. They may also represent the Aortic Quality function in broader APV/ CVG initiatives i.e. continuous improvement projects especially as they pertain to pre-market deliverables. The position has accountability to lead and achieve program objectives through matrixed employees/teams who are not direct reports.

 

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.

 

AORTIC offers treatment for vascular abdominal and thoracic aortic disease through catheter-based procedures and diagnostic technologies.


A Day in the Life

 

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.
  • Represents, leads, and is accountable for the Quality function on the Core Team.
  • Partners with Subject Matter Experts to drive development of clear objectives. for education packages that improve competency.
  • 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.
  • Partners with management to lead quality initiatives that develop and maintain a high performing, scalable, and compliant Quality System.
  • Interprets government regulations, agency guidelines, and internal policies to assure compliance.
  • Guides the architecture, governance, and measurement of the program.
  • Establishes meaningful metrics.
  • Prepares quality reports
  • Consults on development of quality improvements and recommends alternatives.
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 program management or advanced degree with 3+ years of experience in quality and/or program management.

 


Nice to Have


 


  • Regulated industry experience (medical device, biotech and pharma)

  • Proven ability to manage the activities of one or more small / medium scale projects or sections of projects.

  • Strong leadership capabilities; building, motivating, coaching and directing cross-functional teams and team members to meet project objective

  • Practical project /program management experience

  • Experience working in multiple functional disciplines e.g.: Design assurance, Quality engineering, Process Development, R&D, Clinical/ Regulatory ideally in Class III devices

  • Proven ability to interface and influence executive leadership.

  • Ability to exercise independent judgment or initiative.

  • Demonstrates strong understanding of technical and business PDP requirements

  • Clinical Acumen particularly as it relates to Endovascular therapies

         
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 may be required to support project objectives less 10% 

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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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