Manager, Document Control

The Manager, Document Control will report to the quality management organization, and lead the development, management, and execution of document control programs in support of the QA/RA function.

This position is responsible for managing and maintaining Quest's documents and document control system, including document creation, revision control, approval, publication, retrieval, distribution, and archive of all documents within Quest's quality management system.

This is a hybrid position and requires 3 days on site at Quest's Lewisville, TX lab.

Document Management

• Maintain and oversee all quality documents and records to ensure accuracy, completeness, and compliance with applicable regulatory/standard requirements and established company procedures/policies/systems.
• Receive policy/process changes from multiple sources (e.g. Regulatory, Quality, Product, R&D, etc.) and apply appropriate update actions
• Manage and maintain the full lifecycle of all controlled documents in the quality management system (QMS) and electronic quality management system (eQMS).
• Oversee the creation of new documents, ensure proper formatting, version control, and approval processes are followed.
• Create, maintain, and revise document templates.

Document Distribution, Retrieval, and Compliance

• Distribute documents to relevant stakeholders and manage requests for document retrieval.
• Ensure all documents are compliant with company policy, regulation requirements, and standards.
• Maintain hard copy records in accordance with Quest's retention policy.

Training and Support

• Provide training to employees on document control procedures and best practices.
• Partner with cross-functional areas to support timely periodic review, gather document requirements, facilitate document updates, assignment of training documents, and resolve document-related issues.
• Maintain and implement improvements to the document control and record retention program.
• Drive execution change control activities related to document and training.
• Drive generation of documents, quality records in support of internal and external audits activities.
• Drive generation and preparation of documentation, records, and other artifacts in support of regulatory submissions.

Required WorkExperience:

• 5 years of experience in document control in the medical device and/or IVD industry.
• Previous experience with implementing, maintaining, and/or managing electronic quality management systems (e.g., SmartSolve, MediaLab, Veeva, etc.) in a regulated environment.
• Experience applying Medical device regulations (e.g. FDA 21 CFR Part 803, 21 CFR Part 806, 21 CFR Part 820, ISO 13485, ISO 14971, ISO 15189, IVDR, CAP, and CLIA).

Preferred Work Experience:

• Technical writing
• ASQ or medical device related certification

Physical and Mental Requirements:

• Strong attention to detail for thorough documentation to ensure consistency in documentation.
• Excellent problem-solving skills to identify and address quality issues effectively.
• Ability to work under pressure and meet deadlines, while maintaining accuracy.

Knowledge:

• Broad-based technical knowledge and skills in diverse areas of business such as quality engineering, quality assurance, quality systems, regulatory affairs, laboratory operations, GCP, and GMP operations.
• Strong working knowledge of applicable regulations, such as but not limited to, the medical device regulations: FDA 21 CFR Part 820 Quality Systems Regulations/new Quality Management System Regulation and ISO 13485 standards. Preferred: ISO 14971, ISO 15189, IVDR, CAP, CLIA, and NYSDOH requirements.

Skills:

• Ability to manage large volumes of documents systematically and efficiently.
• Demonstrated strong analytical thinking skills and attention-to-detail.
• Strong communication and effective interpersonal skills to collaborate with various departments and stakeholders.
• Ability to clearly communicate, both verbal and written, with all levels of organization.
• Must be able to work/support multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies.
• Proficient technical writing and document management tools (e.g., Microsoft Word, Microsoft Visio, Microsoft Excel, and Adobe) and with quality systems.
• Ability to work independently and collaboratively with cross-functional departments in a fast-paced environment with minimal supervision.
• Proficient in document management systems.