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Search Results for Quality Specialist
Job Title. Location Salary Actions

Quality Engineer

Role: Quality Engineer Location: Mullingar, Westmeath (On site) Benefits: Good salary, pension, healthcare and yearly bonus. Company: My client are an exciting business located in a modern state of the art facility in Mullingar Co. Westmeath. Passionate about serving the world’s medical device and allied healthcare industries in offering a range of the highest quality innovative healthcare packaging solutions. Role: Reporting to the Senior Quality engineer and/or Quality and Regulatory Director the Quality Engineer will work in collaboration with the s...

Location: Athlone, Cavan, Dublin, Kildare, Longford,
Quality Engineer 		EU Not Disclosed

Quality Compliance Lead

Our client is a global healthcare leader with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. They serve the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. This plant in Donegal manufactures blood glucose test strips and sensors for use in diabetes management. They are currently seeking a Quality Compliance Lead who’s main responsibility shall be to lead Site Audit Readiness and be a member of the Quality Systems team in the Quality D...

Location: Donegal,
Quality Compliance Lead 		Donegal Not Disclosed

Senior QA/RA Specialist

Senior QA/RA Specialist Our client a newly established Medical device company are currently seeking a Senior QA/RA Specialist to join their team. Reporting to the Head of Quality the QA/RA Specialist will assist Head of Quality in implementing new Quality Management Systems, establishing entity as a legal manufacturer and supporting the development of their new Product portfolio. The Senior QA/RA specialist will have strong knowledge of regulatory processes for EU and FDA product clearance and experience of quality in the context of R&D and design ...

Location: Galway,
Senior QA/RA Specialist 		Galway Not Disclosed

Quality Manager

Our client is a leading Irish Pharmaceutical organisation in the area of Animal Health. Since their inception, over 40 years ago, they have succeeded in manufacturing, registering and marketing a diverse range of products in over 40 countries worldwide. Their products range from sterile injectables, intramammary, anthelmintics, oral powders, premixes and nutritional supplements providing cost-effective superior treatments for a range of conditions. Due to internal promotion & expansion they have a position for a Quality Assurance Manager who will head up thei...

Location: Cavan,
Quality Manager 		Cavan Not Disclosed
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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.