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Senior Quality Systems Specialist

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Quality
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19000CY8 Requisition #

Careers That Change Lives

 

In this exciting role as a Senior Quality Systems Specialist, you will have primary focus responsibility to lead CAPA, QMS Harmonization, and Audit activities for the Medtronic Neurovascular business.

The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

 

BRAIN THERAPIES offers an integrated portfolio of devices
and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improve the precision and workflow of neuro procedures.

 

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 required 
  • Minimum of 4 years of experience, or advanced degree with 2 years of experience

 

Nice to Have: (Preferred Qualifications)

 

·       Degree in Science or Engineering

·       Experience with metrics development and data analysis

·       Experience working with CAPA, Management Review and Change Control processes

·       Experience with Audits (Internal and External) and leading the front or back room processes

·       Experience with TrackWise and Agile PLM software

·       Experience with quality tools and process improvement techniques

·       Strong critical thinking and analytical skills

·       Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques

·       Lean Sigma certified or demonstrated problem solving experience

·       Independent compliance decision maker (based on knowledge of regulations, available relevant information, alternatives, risk)

·       Influence management skills; ability to work constructively across all functions of the organization and build relationships

·       Strong technical writing and documentation review skills

 


Benefits: 

Industry-leading Healthcare

Competitive Retirement and Stock   Programs

Educational Resources and Financial Assistance

Family Care Leave

Matching Gift and Volunteer Grants

Opportunities to Network and Grow

Mentoring

Flexible Paid Time Off

Well-being Resources, Activities and Rewards

A “Thank-You” Culture



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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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.

WORKING AT
MEDTRONIC

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