Job Summary
The Document Management and Training Leader will be responsible for overseeing the creation, organization, maintenance, and control of all documentation related to medical device design, development, and manufacturing processes. This role will also lead the development and execution of training programs to ensure that all personnel are proficient in the use of documentation systems and are compliant with regulatory and quality standards. The ideal candidate will have a deep understanding of medical device regulations, document management systems, and adult learning principles.
Responsibilities
1. Document Management:
Develop and maintain a comprehensive document management system (DMS) to ensure all documentation is organized, easily accessible, and compliant with industry regulations.Oversee the creation, revision, and approval process for documents, including standard operating procedures (SOPs), work instructions, and technical manuals.Ensure all documentation is up-to-date and reflects current regulatory requirements, company standards, and best practices.Implement document control protocols to manage the distribution, review, and archiving of documents.Conduct regular audits of documentation to ensure accuracy, completeness, and compliance with internal and external standards.2. Training Program Development:
Design, develop, and implement training programs that ensure all employees are proficient in the use of the document management system and understand regulatory requirements.Create and assign training materials, including manuals, e-learning modules, and videos, tailored to different levels of users.Collaborate with subject matter experts to develop training content that is relevant and up to date with industry standards.Schedule and conduct training sessions, both in-person and virtually, to accommodate the needs of all employees.Evaluate the effectiveness of training programs through assessments, feedback, and performance metrics, and make necessary adjustments.3. Regulatory Compliance:
Ensure that all documentation and training programs comply with relevant regulatory standards, such as ISO 13485 and FDA 21 CFR Part 820.Stay current with changes in regulatory requirements and update documentation and training programs accordingly.Prepare for and participate in regulatory inspections and audits, providing documentation and training records as required.4. Team Leadership and Collaboration:
Lead the document control and QMS training processes, providing guidance and direction to the users.Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, R&D, and Manufacturing, and Service to ensure alignment and integration of documentation and training efforts.Act as a key point of contact for document management and training-related inquiries and issues.5. Continuous Improvement:
Identify opportunities to enhance document management and training processes through the implementation of new technologies, tools, and best practices.Drive continuous improvement initiatives aimed at increasing efficiency, reducing errors, and enhancing the overall quality of documentation and training programs.Minimum Requirements
- Bachelor's degree in a related field (e.g., Quality Management, Life Sciences, Engineering) required; Master's degree preferred.
- Minimum of 5 years of experience in document management, training development, or a related role within the medical device or pharmaceutical industry.
- In-depth knowledge of regulatory requirements for medical devices, including ISO 13485 and FDA 21 CFR Part 820.
- Proven experience with document management systems (DMS) and electronic quality management systems (eQMS).
- Strong leadership skills with experience managing teams and projects.
- Excellent communication skills, with the ability to convey complex information clearly and concisely.
- Experience in developing and delivering training programs, with a solid understanding of adult learning principles.
- Detail-oriented with strong organizational and problem-solving abilities.
- Proficiency in Microsoft Office Suite and other relevant software.
Preferred Skills
- Certification in Quality Management (e.g., Certified Quality Auditor, Certified Quality Engineer).
- Experience with Lean, Six Sigma, or other continuous improvement methodologies.
- Familiarity with e-learning development tools (e.g., Articulate, Captivate).
- Familiarity with the Propel eQMS system.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
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