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Search Results for Quality Specialist
Job Title. Location Salary Actions

Senior Quality Engineer

SENIOR QUALITY ENGINEER Our Client, One of the largest medical device companies based in Galway is currently recruiting Senior Quality Engineer . The successful candidate will lead and work as part of a team to maintain high quality and performance standards on all Medical products. Reporting to the Operations Quality Manager, the position will be challenging and will require an ability to lead a team and work on own initiative and with minimum supervision. The Role • Lead and drive QA initiatives within area of functional responsibility. • Provide quality inpu...

Location: Galway,
Senior Quality Engineer
Galway Not Disclosed
Other Quality Assurance Jobs
Job Title Location Salary Actions
Quality Assurance Specialist Dublin West €45000 - €50000
QA Senior Associate (Contract) Dublin Not Disclosed
Quality Assurance Specialist Dublin West €45000 - €50000

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.