Sr Quality Systems Spec

hace 2 semanas

Bogotá, Bogotá D.E., Colombia Medtronic A tiempo completo

Careers that Change Lives
**A Day in the Life
**Responsibilities may include the following and other duties may be assigned.

  • Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
  • Represent Quality for Service Operations (also referred to as Service & Repair) across the Global Region.
  • The specialist will represent the organization in strategic decision making for the process.
  • The specialist will need to coordinate escalations and see them through to resolution.
  • The role will require partnership with multiple cross functional partners and require clear communication and ability to influence up and execute change management within organizations.
  • Lead the harmonization and standardization of the Quality Management System for Service Operations within the Global Region.
  • Own the project plan.
  • Engaging with stakeholders.
  • Understanding the current state.
  • Pushing what the future state can be.
  • Detailed timeline for execution.
  • Execute the plan.
  • Ensure completion of activities.
  • Use escalation pathways and mitigation activities as needed.
  • Communicate updates to leadership

Other responsibilities may include:

  • Supports Service & Repair Quality Management System activities in compliance with Medtronic policies and international regulations and standards.
  • Maintains the Company/Service & Repair QMS including implementation of QA team objectives.
  • Manages the creation, development /review and approval of changes to quality documents, such as procedures, Work Instructions and Job Aides.
  • Followup on Corrective and Preventative Actions (CAPA) and related tasks, coordinate with task owners to ensure timely completion of tasks.
  • Supports internal and external audits.
  • Generates and presents Quality Management Review.

Must Have:
Minimum Requirements

  • Bachelor degree in biomedical engineering or related areas.
  • 3 or 4 years of relevant experience with audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
  • Fluent English level.
  • Requires advanced knowledge in audits and different projects.
  • May have practical knowledge of project management.
  • Ability to assess complicated problems and drive solutions.
  • Teamplayer.
  • Excellent organizational and communication skills.
  • Communicates with internal customers regarding ongoing operations. Uses information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties.
  • Practical knowledge in leading and managing the execution of processes, projects and tactics. Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization.
  • Data analysis and improvement of processes.
  • Knowledge in MS Office.

Nice to Have

  • Prior experience in medical device regulated field.
  • Experience in Agile MAP and TrackWise systems.
  • Advanced Excel skills for analytics and assessment.
  • Established and productive individual contributor.
  • Practical knowledge of program management skills.

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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