R&D Documentation Control and Configuration Management Specialist

JOB SUMMARY

The R&D Documentation Control and Configuration Management Specialist is responsible for establishing, maintaining, and governing the R&D documentation repository to ensure accuracy, compliance, traceability, and version integrity across all product development activities. This role controls document creation, review, approval, release, revision, archival, and obsolescence processes while ensuring that design changes, Engineering Change Notices (ECNs), Design Change Notices (DCNs), and related records are properly managed and communicated. The position also serves as the custodian of document quality standards and repository governance.

Key Responsibilities

Document Repository Management

• Maintain and administer the R&D document management system and repository.

• Ensure proper organization, indexing, storage, retrieval, and security of technical documents.

• Control document access rights and maintain confidentiality of proprietary information.

• Manage document retention and archival processes according to company and regulatory requirements.

• Serve as the primary point of contact for document repository-related issues and improvements.

Document Control

• Process and coordinate document entry, review, approval, distribution, revision, and withdrawal activities.

• Ensure all documents follow established templates, standards, and naming conventions.

• Maintain document lifecycle records and ensure complete audit trails.

• Verify completeness and accuracy of supporting documentation prior to release.

• Prevent the use of obsolete documents by maintaining effective revision controls.

Configuration and Version Management

• Manage document version control for all R&D specifications, procedures, drawings, reports, test methods, and design records.

• Maintain configuration baselines throughout product development and commercialization.

• Ensure proper tracking and implementation of document revisions.

• Coordinate document updates resulting from product changes, regulatory updates, or process improvements.

• Generate and maintain revision histories and change logs.

Design Change Notice (DCN) and Engineering Change Management

• Administer Design Change Notices (DCNs), Engineering Change Orders (ECOs), and Engineering Change Notices (ECNs).

• Facilitate document routing, review, approvals, and implementation of design changes.

• Verify that all impacted documentation is updated and released appropriately.

• Track change status and ensure timely closure of change requests.

• Maintain complete traceability between change requests, approvals, and revised documentation.

Document Quality Assurance

• Review documents for compliance with company standards, formatting requirements, and quality expectations.

• Ensure consistency, clarity, accuracy, and completeness of technical documentation.

• Conduct periodic audits of the document repository to identify gaps and improvement opportunities.

• Monitor document quality metrics and report compliance status to management.

• Support corrective and preventive actions resulting from audits and quality reviews.

Cross-Functional Collaboration

• Work closely with R&D, Engineering, Quality, Regulatory, Manufacturing, and Project Management teams.

• Provide guidance and training on document control procedures and best practices.

• Support internal and external audits by providing documentation and records as required.

• Recommend process improvements to enhance efficiency, compliance, and data integrity.

Qualifications

Education

• Bachelor's degree in Engineering, Science, Quality Management, Technical Writing, Information Management, or a related field preferred.

Experience

• 3-7 years of experience in document control, configuration management, quality systems, or engineering support.

• Experience managing technical documentation in a product development or manufacturing environment.

• Familiarity with change control processes and document management systems.

Preferred Knowledge

• Document Control and Configuration Management principles.

• ISO 9001, ISO 13485, AS9100, IATF 16949, or similar quality management systems.

• Product development lifecycle and engineering change management processes.

• Electronic Document Management Systems (EDMS), PLM, ERP, or Workday systems.

• Regulatory and compliance documentation requirements.

Key Skills

• Strong organizational and document management skills.

• Excellent attention to detail and data accuracy.

• Knowledge of version control and configuration management methodologies.

• Ability to manage multiple priorities and deadlines.

• Effective written and verbal communication skills.

• Analytical problem-solving capability.

• Proficiency with Microsoft Office, SharePoint, PLM, and document management tools.

• Strong collaboration and stakeholder management skills.