Senior Quality Systems Specialist

hace 3 semanas

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

Careers that Change Lives
Support Latin America Region Post Market Vigilance activities related to Field Corrective Action (FCA).

A Day in the Life
Responsibilities may include the following and other duties may be assigned.

  • Support implementation and compliance to the company's Quality Management System.
  • Support establishment of quality specifications and standards and support the preparation of quality process document (e.g. SOP, Regional Package)
  • Observe all health and safety policies and procedures and take all reasonable care that actions or omissions do not impact on the health and safety of others.
  • Work within and actively promote Medtronic's Mission, corporate strategies, policies, procedures and Code of Conduct.
  • Actively communicate and collaborate with PMV team and stakeholders related to FCA and PHO.
  • Prepare reports, analyze trends and opportunities for improvement related to the process.
  • Manage, update and track activities related to FCA and necessary documentation (e.g. CAPA, regulatory enquiries) timely and accurately.
  • Proactively drive and react to system trending to achieve targets and KPI.
  • Support supervisor in leading the team.
  • Demonstrated initiative through problemsolving and system thinking.
  • Other duties as assigned by the supervisor or manager.
  • Ensure FCA are executed as defined in applicable quality documents.
  • Responsible for timely execution, monitoring and closing of FCA throughout Latin America regions.
  • Responsible for the implementation and maintenance of quality metrics and monthly reports for all FCA activities.
  • Ensure that the Company's agreed quality standards (including ISO13485) are maintained with regards to products, procedures, policies, operations and customer contact.

Must Have:
Minimum Requirements

  • Bachelor degree in biomedical engineering or related areas.
  • 13 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.
  • 13 years of experience in managing/handling FCA or PMV activities
  • Good understanding of GDP and its implementation is required. Basic knowledge of ISO 13485 and its implementation will be an added advantage
  • Fluent English level.
  • Ability to assess complicated problems and drive solutions.
  • Team player.
  • 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.
  • Consciously works to bring Medtronic Mission alive.
  • External Focused on internal and external customers, competitive and market driven, leads and supports change.
  • Translates complexity into simplicity, articulates crisply and clearly.
  • Passionate and driven, makes tough decisions in difficult situations.
  • Authentic and sets a vision to inspire performance and engage others.
  • Takes accountability and delivers consistent decisions, actions, and results.
  • Culturally agile, strives to understand diverse market needs and responds with creative and effective solutions in a global structure.
  • Practice the highest ethical standards and integrity in every aspect of the job to ensure compliance.

Nice to Have

  • Prior experience in medical device regulated field.
  • Basic proficiency in Portuguese (speaking and writing).
  • 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 O

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