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Search Results for Quality Specialist
Job Title. Location Salary Actions

Quality Manager RP

Quality Manager & Responsible Person (RP) Our client are hiring a Quality Manager & Responsible Person (RP) to oversee their GDP Quality Management System and maintain compliance across their wholesale distribution sites. Key Responsibilities: Maintain and oversee the company’s GDP Quality Management System, SOPs, and regulatory compliance. Act as the primary contact for the HPRA and lead regulatory inspection readiness and audits. Serve as the Controlled Drug Responsible Officer for specified distribution facilities. Oversee supplier/c...

Location: Dublin,
Quality Manager RP 		Dublin Not Disclosed

Principal Design Assurance Engineer

Job title: Principal Design Assurance Engineer Location: Parkmore Business Park, Galway. Benefits: Excellent salary, bonus, pension, healthcare, opportunity to grow your career with hugely exciting Medical Device organisation. Company: My client are an early stage Irish MedTech company located in Galway, a global centre for excellence in medical technologies. The company collaborates with clinicians and research institutions across the world developing and commercialising a new technology platform for endovascular surgery that wi...

Location: Galway, Galway City,
Principal Design Assurance Engineer 		Galway Not Disclosed

Senior Associate Quality Control

Senior Associate Quality Control AS3646 12 Months Dublin We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties: • Plan and perform analyses with great efficiency and accuracy. • Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays. • Report, evaluate, back-up/archive, t...

Location: Dublin,
Senior Associate Quality Control 		Dublin Not Disclosed

Quality Technician

Title: Quality Technician Location : The Digital Hub, Rainsford St, Dublin 8. Benefits: Competitive salary, Health insurance and Hybrid working Company: My client are a Medical Device company who started up in 2010 and have developed and patented a bimodal neuromodulation technology that it is evaluating for neurological disorders. The lead application of this technology is through a device which has been shown to soothe and relieve tinnitus, a condition affecting 10% of the adult ...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Quality Technician 		EU Not Disclosed

Quality Manager - NPI

Role: Quality Manager - NPI Based in Dun Laoghaire – on site role Benefits: Competitive salary, Healthcare, bonus or share options and Pension contribution, excellent opportunity to expand your career in exciting Medical Device company growing from strength to strength. Company: My client have deep expertise and advanced technologies to continuously innovate their pen needles, insulin syringes and other products. Job Purpose: To provide support for ISO9000/ISO13485 Quality System. Responsible for ensuring adherence to al...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Quality Manager - NPI 		EU 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.