Quality Assurance Specialist Role
The Quality Assurance Specialist plays a vital role in ensuring the development and production of high-quality products that meet regulatory requirements. This position reports to the Operations Manager and is responsible for coordinating with laboratories, approving validation studies, managing complaint investigations, supporting change controls, and leading process improvements.
Main Responsibilities:
* Coordinate the activities of Inspectors to ensure optimal efficiency and compliance with all regulatory requirements.
* Drive root cause analysis of non-conformances with relevant personnel and ensure corrections are implemented before restarting production.
* Maintain Good Manufacturing Practices across all operational departments under quality responsibility and attend departmental meetings as necessary.
* Release batches from packaging to sterilization and final release, complete review of documentation and batch releases.
* Liaise with relevant personnel regarding product flow through the Quality Control department and other issues that arise.
* Analyze and report on customer complaints and institute corrective actions.
This position requires a degree in a Science/Engineering discipline, preferably Polymer Science/Engineering or Mechanical Engineering. Previous work experience in an ISO 9001 environment, coupled with a background in Medical Devices/Pharmaceutical Industry, is essential. A good knowledge of Statistical Process Control methodologies, as well as experience in CAPA system management and FDA requirements, is also required.
Required Skills:
* Scientific Discipline: Degree in a Science/Engineering discipline (Polymer Science/Engineering or Mechanical Engineering preferred).
* ISO 9001 Experience: Previous work experience in an ISO 9001 environment.
* Medical Devices/Pharmaceutical Industry Background: Background in Medical Devices/Pharmaceutical Industry.
* Statistical Process Control Knowledge: Good knowledge of Statistical Process Control methodologies.
* CAPA System Management Experience: Experience in CAPA system management.
* FDA Requirements Knowledge: Good knowledge of FDA requirements.