Quest Diagnostics · 4 months ago
Manager, Document Control (Hybrid Opportunity)
Lewisville, TX
Full-time
Hybrid
Mid, Senior Level
5+ years expQuest Diagnostics is a leading provider of diagnostic information services, and they are seeking a Manager of Document Control to lead the development and management of document control programs within the quality management organization. The role involves overseeing document creation, revision control, compliance, and training related to document control procedures.
BiotechnologyHealth CareHealth DiagnosticsInformation ServicesPrecision Medicine
Responsibilities
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
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
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
Qualification
Required
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)
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
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
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
Preferred
Technical writing
ASQ or medical device related certification
Preferred: ISO 14971, ISO 15189, IVDR, CAP, CLIA, and NYSDOH requirements
Company
Quest Diagnostics
Quest Diagnostics is a clinical laboratory that offers diagnostic testing, services, and information.
10001+ employees
H1B Sponsorship
Quest Diagnostics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (59)
2024 (38)
2023 (74)
2022 (56)
2021 (49)
2020 (45)
Funding
Current Stage
Public CompanyTotal Funding
$2.6B2024-08-15Post Ipo Debt· $1.85B
2023-10-30Post Ipo Debt· $750M
1996-12-17IPO
Leadership Team
James Davis
Chief Executive Officer and President
Cecilia McKenney
SVP & Chief Human Resources Officer
Recent News
2026-01-09
2026-01-06
Company data provided by crunchbase