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Search Results for Quality Specialist
Job Title. | Location | Salary | Actions |
Quality Systems EnginerRole: Quality Systems Engineer 24 month ftc with strong chance of going permanent. Based in Dun Laoghaire – on site role Competitive salary, Healthcare, bonus or share options. Pension contribution from company after 24 months. Job Purpose: Reporting to the Quality Systems Manager, duties will include implementing & maintaining the Company’s Quality Management System in accordance with applicable standards and regulations Responsibilities: Be a key driver of cGMP practices within Operations and Quality divisions Act as a p...Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South, |
EU | Not Disclosed | |
Senior Quality EngineerTitle: Senior Quality Engineer Location: Dublin 1 (Hybrid working) Company: My client are developing a Best-In-Class minimally invasive solution for severe Tricuspid Regurgitation (TR).It is a clear unmet clinical need, with a significant impact on mortality, cardiovascular events and quality of life. With a prevalence greater than aortic stenosis in the population over 65 years, TR is the next structural heart opportunity. Responsibilities: Support the development, implementation, and maintenance of the QMS in accordance with...Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South, |
EU | Not Disclosed | |
Quality ManagerJob title: Quality Engineer/ Quality Manager Location: ATU Ihub, Galway Company: My client are a developer of innovative medical devices which transform the mobility and quality of life of enteral feeding users. Their team understands that current feeding systems are complex, inconvenient and a burden on users’ daily lives. My client have developed the Mobility+® the first of its kind FDA cleared Elastomeric enteral feeding system. The Mobility+® is now available in the US market and has FDA Approval. Overview: As a Quality Engi...Location: Clare, Galway, Galway City, Limerick, Limerick City, |
EU | Not Disclosed | |
Quality EngineerRole: 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, |
EU | Not Disclosed | |
Quality Systems ManagerCompany: My client are have a global portfolio which includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. They are committed to helping create healthier communities worldwide through education, outreach and better access to treatment Role: Quality Systems Manager - Senior Location: Newenham Court, Northern Cross, Malahide rd, Dublin 17 Team: 6 direct reports Hybrid working: 2-3 days a week on site per week Benefits: Compe...Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South, |
EU | Not Disclosed | |
Quality EngineerRole: 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, |
EU | 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.
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Regulatory Affairs | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected]
Copyright © 2012 Life Science Recruitment Ltd
This site uses cookies. For more information on our cookie policy read our Privacy Policy | Terms of Use
Registered as a private limited company. No: 445328 | Web Design / SEO by WebScience | Valid XHTML - CSS