Quality Assurance Specialist - Document Control

About the role

Implement and adhere to document control procedures, including version control, document approval, and archiving. Assist in the development and implementation of Document Change Requests for the company’s controlled documentation, and support the deployment of training materials while maintaining training records.

Responsibilities

• Assist with the initiation and execution of Document Change Requests (DCR) for the release of new or revised Controlled Documents, maintaining DCR and Document Master and Locations files in accordance with established policies.
• Create, format, and edit documentation related to product development, quality assurance, and manufacturing processes, including policies, procedures, Work Instructions, and related Controlled Documents.
• Coordinate and facilitate the review and approval process for new or revised documents by working with relevant departments or stakeholders.
• Assist with scheduling and executing employee training, reviewing and maintaining training plans and records for new hires and current employees.
• Communicate with various departments to gather and disseminate information related to documentation needs.
• Provide support to Quality Assurance, Regulatory Affairs, Engineering, and Production teams by ensuring access to necessary documentation.
• Perform other Quality-related functions and duties as assigned by the manager.

Requirements

• Bachelor’s degree (B.A.) from a four-year college or university; or two to five years of related experience and/or training in medical device manufacturing; or equivalent combination of education and experience.
• Knowledge of Grand Avenue Software (GAS) preferred.
• Working knowledge of US FDA Quality System Regulations.
• Self-starter capable of managing multiple projects simultaneously.
• Proficient computer skills, including knowledge of MS Excel and Word.