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Search Results for Quality Specialist
Job Title. Location Salary Actions

Senior Quality Specialist (Supervisor) - Medical Devices

Permanent Role JOB SCOPE: This position will support the execution of the Site’s Quality Management System Processes and deliver Quality System projects. The successful individual will drive the flawless and compliant execution of the assigned processes to meet customer and business needs while ensuring the processes are in compliance with regulatory requirements. This role will involve liaising with cross functional teams on driving improvement and streamlining of the assigned processes and managing a group of Quality Systems Specialists. The successful candidate will ...

Location: Cork,
Senior Quality Specialist (Supervisor) - Medical Devices
Cork €50000 - €55000

Quality Specialist (Medical Devices)

12 Month Fixed Term Role JOB SCOPE: Reporting to the Quality System Manager you will join a team responsible for improving key Quality System processes including Internal Auditing, NCEs, DCOs, Batchcard / Release sheet review and internal training to staff and operators on quality issues. Provide QA support to manufacturing operations as required. Participate in projects in order to contribute to continuous improvements. This role will involve liaising with cross functional teams on driving improvement and streamlining of the assigned processes. KEY RESPONSIBILITIES: T...

Location: Cork,
Quality Specialist (Medical Devices)
Cork €40000 - €45000

GMP Inspector

GMP Inspector Reporting to a GMP Inspection Manager, the GMP Inspector will be responsible for assessing the compliance of manufacturers with EU Good Manufacturing Practice (GMP). The Manufacturing Compliance Specialist will evaluate the compliance of sites inspected, in Ireland and abroad, with the requirements of National legislation European Community Directives, Regulations and Guidance. These sites may include; • Manufacturers and distributors of medicinal products. • Manufacturers of investigational medicinal products. • Sites involved in ...

Location: Dublin,
GMP Inspector
Dublin Not Disclosed
Other Quality Assurance Jobs
Job Title Location Salary Actions
Analytical Group Supervisor Offaly €50000 - €55000
QC Lab Analyst Sligo Not Disclosed

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.