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Search Results for Quality Specialist
Job Title. Location Salary Actions

Senior Supplier Quality Engineer

Senior Supplier Quality Engineer POSITION SUMMARY: • Reporting to the Senior Manager, Global Supplier Quality, the Senior Supplier Quality Engineer is

Location: Westmeath,
Senior Supplier Quality Engineer 		Westmeath Not Disclosed

Quality Specialist

Quality Specialist Our Client are a global BioPharmaceutical company committed to scientific excellence and/or Research & Development innovation to bring

Location: Dublin,
Quality Specialist 		Dublin Not Disclosed
Other Quality Assurance Jobs
Job Title Location Salary Actions
Head of Quality Dublin West €100000+
QA Specialist - CN002 Dublin Not Disclosed
Director Device Program Lead Dublin Not Disclosed
Snr QA Officer Dublin North Not Disclosed
Microbiology Quality Lab Supervisor Limerick Not Disclosed
Supplier Quality Data Analyst Westmeath Not Disclosed
Quality Assurance Officer Waterford Not Disclosed
Quality Director Dublin €100000+
Quality Director Dublin €100000+
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Quality Specialist Career Profile

Quality Specialist


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.