Quality Document Control Specialist SSC

Medtronic

Responsibilities
Company Type
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Careers that Change Lives


A Day in the Life

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

  • Change Analyst for Americas/LatAm Quality System Documentation.

  • Super User for MAP (Medtronic Agile Program) system. Supports and educates organization in process/tool use.

  • Support the Quality System Architecture and Quality System processes, ensuring integration between Americas region and business partners and corporate.

  • Monitor process metrics in process areas such as Info Mgmt and Change Control process.

  • Support development and delivery of a variety of types of Quality System training

  • Support the development and continuous improvement of Quality System policies, procedures, tools, training programs, and interpretation of regulatory requirements.

  • Be a change agent for the organization. Identify, facilitate, and implement changes to improve efficiency, compliance and reduce complexity of processes as required.

  • Support additional Quality Systems projects as needed.

  • Participate in Quality System Audits as requested.

  • Partners with BU Quality Specialists to leverage best practices across Medtronic.

  • Support and manage timely input to quality related RA/QA scorecard measures.

  • Additional duties may be required based on business needs.

  • 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 standards and agency guidelines.



Must Have: Minimum Requirements 

  • B.S. Degree.

  • Fluent in Spanish and English.

  • Ability to travel and work virtually with all parts of the region.

  • 2+ years’ experience in a quality role for medical devices and/or pharmaceuticals.



Desired/Preferred Qualifications

  • Previous experience supporting quality system audits.

  • Strong technical writing and documentation review skills.

  • Experience with quality tools and process improvement techniques.

  • Strong critical thinking and analytical skills.

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

  • Working knowledge of medical quality system regulations.

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

  • Experience writing and reviewing of technical documentation.


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 above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

The physical demands described within the Day in the Life 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.


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Confirmed 2 hours ago. Posted 30+ days ago.

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