Quality Assurance Specialist / Document Controller Role
We are seeking a Quality Assurance Specialist/Document Controller to join our team. The ideal candidate will have excellent initiative and troubleshooting skills, as well as strong interpersonal skills and the ability to communicate effectively both verbally and in writing.
About this role:
This is a unique opportunity for someone who enjoys working with documentation, ensuring compliance with regulatory requirements, and maintaining accurate records. You will be responsible for performing batch history record review while providing support to all areas within the company.
Main Responsibilities:
• Performing Batch Record Review - Release raw materials, components, and finished devices.• Review & Approval of Protocols, Reports & Documentation Updates: Ensure compliance with company procedures/policies and regulatory requirements.• Utilizing Statistical QA Methods - Track quality performance trends in production environment.• Maintaining QMS Requirements Compliance: ISO13485,MDSAP ,IVDD, IVDR ,FDA … ensure accuracy thru audits etc..
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