Specialist - Quality Assurance

This position is responsible for:

? Implement and adhere to document control procedures, including version control, document approval, and

archiving

? Create and Edit Documents: Prepare, format, and edit documentation related to product development, quality

assurance, and manufacturing processes.

? Coordinate Reviews: Facilitate the review and approval process for new or revised documents by

coordinating with relevant departments or stakeholders

? Assisting in the development and implementation of the Document Change Requests for the company’s-

controlled documentation.

? Assisting with the deployment of training materials to the company's employees and maintaining resulting

training records.

? Other Quality related functions that may be assigned

? Bachelor’s degree (B.A.) from four-year college or university; or two to five years related experience and/or

training in medical device manufacturing; or equivalent combination of education and experience.

? Possess working knowledge of US FDA Quality System Regulations.

? Self-starter capable of managing multiple projects at one time

? Good working computer skills; knowledge of MS Excel and Word.

Primary Job Responsibilities

?Assist with the initiation and execution of Document Change Requests for the release of new or revised

Controlled Documents with respective departmental personnel; maintain DCR and Document Master and

Locations specific files in accordance with established policies and procedures.

?Assist in drafting and reviewing new and revised documents, including but not limited to, policies,

procedures, Work Instructions, and related Controlled Documents.

?Assist with the scheduling and execution of employee training with respective department / function

management by 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.

?Support Teams: Provide support to Quality Assurance, Regulatory Affairs, Engineering and Production

teams by ensuring that they have access to the necessary documentation

?Other duties as may be assigned by manager.