MicroVention is now Terumo Neuro

Manager, Document Control - CR

Position Overview

Responsible for the management and oversight of the local document control system and processes to ensure compliance with organizational procedures and applicable external regulations for the Costa Rica site. Support other areas in quality systems as needed. Job duties:
  • Oversee the document management process, including the creation, revision, approval, distribution, and storage of technical, regulatory, quality, and manufacturing documents.
  • Ensure the Company’s document control systems are compliant with all regulatory and industry standards such as ISO13485, 21 CFR FDA 820, MDSAP, and other applicable regulations.
  • Maintain the document system and ensure proper implementation across the organization.
  • Collaborate with other departments to ensure that documents are properly managed and controlled throughout their lifecycle.
  • Ensure all documents are created, updated, and retained in compliance with global regulatory requirements and industry best practices.
  • Facilitate internal and external audits by ensuring that all required documentation is available and audit ready.
  • Ensure effective communication with internal teams to address document related issues, including revisions, audits, and non-conformance investigations.
  • Oversee records retention programs to ensure that records are maintained in compliance with regulatory retention periods. Ensure traceability of all changes, updates, and revisions to documents for full auditability.
  • Manage and mentor the Document Control team, ensuring that all team members are trained in document control procedures and systems.
  • Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
  • Perform additional duties as assigned.

Job Details

Job ID 12704BR

Alajuela, Costa Rica

Apply for this job
    1. Bachelor’s degree or equivalent combination of education and relevant experience.
    2. A minimum of six (6) years of document control experience in the medical device industry.
    3. A minimum of five (5) years in a supervisory position within the medical device industry.
    4. B2 or higher level of written and spoken English proficiency.
    5. Working knowledge of ISO 13485, FDA 21 CFR Part 820, 21 CFR Part 11, MDSAP, MDD, and MDR regulations.
    6. Experience with Quality Systems and document control software.
    7. Good organization skills and attention to detail.
    8. Successful experience working independently, effectively, and confidently in a team environment.
    9. Ability to communicate effectively (verbal and written) and partner with associates at various levels within the organization.
    10. Knowledge of external standards related to Quality Systems.
    11. Proficient with MS Word, Excel, PowerPoint, Visio, Outlook, and Teams.
    Desired Qualifications
    1. Ability to handle multiple projects concurrently.
    2. Strong interpersonal skills, team player with good problem-solving ability.
    3. Familiar with LMS and DMS systems.
    4. Strong project management skills Certification in Quality Management (CQM).