Sr. Manager, Document Control - CR
Position Overview
Responsible for the management, oversight, and continuous improvement of the document control systems, processes, and procedures to ensure the compliance with organizational procedures and applicable external regulations for the Costa Rica site. Support other areas in quality as needed. Job duties:
- Oversee the entire document 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 a 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.
- Continuously review and optimize document control processes to improve efficiency and effectiveness. Lead and support continuous improvement process initiatives in the Costa Rica Document Control area.
- 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.
- Bachelor’s degree in engineering, Life Sciences, Quality Assurance, or related field.
- A minimum of eight (8) years of experience in document control or quality systems experience for medical device industries, with at least five (5) years in a leadership Managerial position within the medical device industry.
- Working knowledge of ISO 13485, FDA 21 CFR Part 820, 21 CFR Part 11, MDSAP, MDD, and MDR regulations.
- Experience with Quality Systems and document control software.
- Good organization skills and attention to detail.
- Strong leadership skills.
- Successful experience working independently, effectively, and confidently in a team environment.
- Ability to communicate effectively (verbal and written) and ability to partner with associates at various levels within the organization.
- Knowledge of external standards related to Quality Systems.
- Proficient with MS Word, Excel, PowerPoint, Visio, and Outlook.
- Ability to handle multiple projects concurrently.
- Strong interpersonal skills, team player with good problem-solving ability.
- Familiar with LMS and DMS system implementation.
- Strong project management skills.
- Lean Six Sigma, Quality, and/or Project Management certifications.
- Certification in Quality Management (CQM)