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Sr Quality Systems Program Manager

21000TI2 Requisition #

Sr Quality Systems Program Manager
Req Number

Location Mounds View, MN

Careers That Change Lives 

In this exciting role as a Sr Quality Systems Program Manager, you will have responsibility for managing various aspects of the Quality System and Compliance Related Programs. You will be responsible for hosting internal audits and inspections from Regulatory agencies at the Mounds View site. The Sr Program Manager must be self-directed with the ability to take initiative and be accountable for results, and must be team oriented with the confidence, maturity and integrity to lead effectively. This position also provides the right individual an opportunity to work with cross functional teams to grow in the quality organization.

Cardiac Ablation Solutions

Cardiac Ablation Solutions offers cardiac mapping and ablation solutions for arrhythmia management.

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.

Must Have: Minimum Requirements  
To be considered for this role, please ensure the minimum requirements are evident on your resume.

Bachelors degree with 7+ years of experience in Quality, program management and/or regulated industry OR Advanced degree with 5+ years of experience in Quality, program management and/or regulated industry. 

Nice to Have (Preferred Qualifications)

  • 5+ years of project management experience in a matrix organization
  • Proven leadership and business acumen; performance-driven.
  • Strong written and oral COMMUNICATION skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience)
  • Strong COLLABORATION and INFLUENCE skills (build relationships, leverage others, align and work towards shared outcome-based goals, etc.)
  • Experience handling ambiguous work direction from various parts of the organization
  • Experience in a highly regulated industry, preferable implantable medical devices
  • Change agent -- willingness and ability to lead and institute change
  • Influence management skills; ability to work cooperatively at all levels in matrix environment to build and maintain the positive relationships required to accomplish organizational goals. 
  • Excellent communication skills and interpersonal/team effectiveness -- ability to succinctly and accurately communicate to various levels of management. 
  • Effective decision-making skills -- experience balancing decisions and priorities across needs of several functional departments and willingness to make tough and timely decisions in the face of risk and uncertainty.

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)

10% Travel internationally and locally.

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