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Mgr, QA Sys and CAPA

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Job Type
Direct Hire
Oct 10, 2016
Job ID
Main Objective:
The Manager, Quality Systems and Regulatory Compliance is responsible for managing, improving and maintaining the global Quality Management System (QMS) to ensure compliance to FDA QSR, ISO 13485, and all other applicable regulatory requirements. 
Essential Duties and Responsibilities:
  1. Ensure that the global QMS is maintained to comply with the most current applicable FDA, ISO and other international regulations.  Provide training to relevant personnel as required.
  2. Lead, manage and develop a staff of Managers and Supervisors, which may include Specialists and Coordinators.
  3. Develop, implement and manage an integrated global risk management program.
  4. Coordinate and lead external regulatory inspections.
  5. Coordinate and support all QMS Management Review activities.
  6. Manage the product complaint process, adverse event reporting and related systems.
  7. Manage the NCR/CAPA process and related systems.
  8. Coordinate and manage the product field action process.
Education and Experience:
Bachelor’s degree required, preferably in an Engineering or Science discipline.  Minimum of ten years related experience required in a medical device or similar regulated environment, with a minimum of five years of related quality management experience.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
  • Must have a strong CAPA background
  • Strong working knowledge of FDA Quality System Regulation, ISO 13485 and applicable international regulations. 
  • Meets deadlines consistently.
  • Strong problem-solving skills, initiative and motivation for improvements.
  • Good project management skills.
  • Strict attention to detail.
  • Excellent communication skills are essential. 
    Machine, Tools, and/or Equipment Skills:
    Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), PowerPoint, SAP or similar business software.