Sr. Doc Control Analyst

Sr. Doc Control Analyst

Work Location: Middlesex County, Massachusetts

Summary:

The Sr. Doc Control Analyst oversees the management, maintenance, and continuous improvement of document control elements within the Quality Management System. This role ensures effective change management, training, and record management processes, supporting both ongoing operations and new product development initiatives.

Responsibilities:

• Oversee and maintain all aspects of document control for the Quality Management System, ensuring compliance with established requirements.
• Administer and provide user support for document and training management systems, including system training and troubleshooting.
• Ensure accurate revision control and manage the document obsolescence process for Quality System and Engineering documentation.
• Develop, maintain, and archive documentation and records to support document control functions and audits.
• Administer the full lifecycle of Document/Engineering Change processes, ensuring timely and accurate processing.
• Collaborate with cross-functional teams to support new product development and sustainment activities, including document and record planning and auditing.
• Evaluate documents and changes for accuracy and compliance with procedures, and develop training materials to support process understanding.
• Generate and distribute reports and metrics related to document control and training, supporting continuous improvement and compliance efforts.

Qualifications:

• Bachelor’s Degree (BA or BS) in a related field preferred, or equivalent experience.
• 5-7 years of experience managing a document control process within ISO9001 or ISO13485 environments.
• Direct experience with Oracle/Agile PLM and training management systems.
• Strong skills in Microsoft Word, Excel, Visio, Teams, and experience working with complex databases.
• Proficient in data collection, database creation, and generating reports and metrics.
• Ability to interpret drawings, procedures, and work instructions, and develop comprehensive Bills of Materials.
• Strong influencing, communication, and presentation skills, with the ability to work effectively in cross-functional teams.
• Experience with comprehensive document control systems and knowledge of Good Documentation Practices (GDP).
• Effective problem-solving and decision-making abilities.

Published Category: Quality & Validation