Quality Management Systems Specialist

hace 2 semanas

Bogotá, Bogotá D.E., Colombia Zimmer Biomet A tiempo completo

Requisition Number:
AMER28362

Employment Type:
Full-time

Location:
Bogota

Job Summary:
This is an experienced level position in Quality Management Systems (QMS). This position requires an understanding of applicable global regulations.

The Corporate QMS Specialist supports policy and procedures responsibilities, including but not limited to assignment of assessments related to global regulation changes and monitoring of the process, support CAPA processing, support harmonization of procedures, schedule meetings with cross-functional team members and generates global communications and status updates for QMS elements.


Principal Duties and Responsibilities:

  • Understand and applies Global regulations to business practices and provides input, advice, and guidance thru the process to assess global regulation changes
  • Monitors the timely completion of Standards and Regulation changes and Global SME Trigger meetings and ensures proper documentation is maintained
  • Support regulatory and business impact assessments of new or revised guidance, regulations, and standards, as necessary.
  • Monitoring Triggers into the Global SME Process and provides output to Global SME for further processing
  • Generates corporate communications, including status reports and analyses, to the quality management team and other business partners.
  • Supports Corporate CAPA team on the monitoring, maintenance, and processing of Corporate Issue Evaluations and CAPAs
  • Provides QMS support to functional business partners
  • Provide support in drafting new or changing global procedures
  • Collaborates with Global Document Control team in processing standards and regulations assessments in Windchill
  • Plan and host meetings in support Global QMS activities

Expected Areas of Competence:

  • Demonstrated strong writing and communication skills
  • Strong attention to detail, ability to multitask
  • Knowledge of overall business environment, medical device industry and the marketplace
  • Mastery of relevant regulations pertinent to medical devices, biologics, drugs and combination products
  • Ability to function well as a member of the team and build relationships between QMS and other areas
  • Able to identify and communicate risks in QMS strategies
  • Knowledge of FDA regulations, EU, MDD, MDR, Australia, China, Japan, Brazil and Canada is US preferred Basic computer skills, including Microsoft Office Suite

Education/Experience Requirements:

  • Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred
  • English Proficiency is required.
  • Knowledge of US FDA, EU, and Global regulations applicable to medical devices is preferred
  • A minimum of one year of experience medical device industry preferred
  • A minimum of 13 years of experience in Regulatory Affairs, Engineering, Quality, or related field is required A combination of education and experience may be considered

Travel Requirements: 10%

Additional Information: 1

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