Specialist - Quality Assurance

Description

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
  
  

Requirements

• 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.