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Quality Specialist Career Profile
The Quality Specialist is responsible for the review, approval and processing of document change requests, assisting in the development and maintenance of the quality management system, acting as Lead Auditor, developing quality KPIs and supporting the complaint handling process. Typically the QA Specialist will have a degree in Life Science or Pharmacy and have 2-3 years experience in the area of quality assurance and will ideally have experience within the quality departments of a Medical Device company or a regulatory agency.
Key responsibilities of the Quality Assurance Specialist
- Ensuring that area procedures are correct and updated as necessary.
- Review of document change requests to evaluate each change for quality related issues.
- LMS administrator for QA function.
- Assist in the development and maintenance of the quality system as required, ensuring compliance to ISO13485:2003.
- Provide guidance to Technical Service and Customer Service on quality system issues.
- Contribute to making the operation efficient and compliant by effective liaison with all departments in quality matters.
- Facilitate internal audits of the systems and processes on a regular basis as performed by the internal audit team. Act as Lead Auditor.
- Participate and report at management review and assist in resolving issues that may arise.
- Conduct QMS training for all employees.
- Participate in the development of the department KPIs. Assist in the preparation of internal statistical reports (KPIs).
- Schedule, chair and report at routine quality focused meetings influencing change and developing best practices.
- Function as QA support in handling Corrective and Preventive Action requests in the internal CAPA system.
- Liaise with external groups in relation to complaint handling systems i.e. complaint investigation centres and complaint management centres.