Assoc Quality Systems Spec
Medtronic
El Coyol, Alajuela, Alajuela, Costa Rica
hace 5 horas

Careers that Change Lives

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

  • Bachelors degree required
  • 1 years of experience required
  • Excellent verbal and written English and Spanish communication skills
  • Nice to Have

  • Certified Lean Six Sigma (Green Belt or Black Belt).
  • Extensive knowledge and understanding of Global and Local policies and procedures relevant to Quality which includes compliance & regulatory, control for manufacturing Medical Devices.
  • Lean Sigma, Power BI, SAP (desired)
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