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Search Results for Quality Specialist

Job Title.	Location	Salary	Actions
Senior Quality Engineer Job title: Senior Quality Engineer Location: Glasnevin, Dublin 11 (on site role) Benefits: Top salary, Bonus, pension and Healthcare Company: My client are currently running clinical trials across Europe and the US, in collaboration with leading researchers and scientists who share our commitment to transforming the lives of the millions of people living with heart failure. They have a diverse team who respect each other’s opinions and work and learn together in an open and honest way to achieve their ambitious purpose. Job Overview: To driv... Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South, Senior Quality Engineer	EU	Not Disclosed
Reg Affairs Specialist Role: Regulatory Affairs Engineer Location: Parkmore, Galway (Hybrid working) Benefits: Top salary Company: My client are a growing Medical Device company who have recently moved into a high tech new site in Parkmore. They have developed an innovative new technology to improve the performance of Vascular stents. Role: Reporting to the Senior Regulatory Affairs Manager, as a Regulatory Affairs Specialist you will play a key a key role in the implementation of post-market activities within Veryan. This is a ... Location: Connaught, Galway, Galway City, Leitrim, Limerick, Reg Affairs Specialist	EU	Not Disclosed
Quality Engineer Job title : Quality Engineer Location: Galway Business Park, Dangan Benefits: Competitive salary, 10% bonus, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages. Company: My client an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease. This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention. ... Location: Galway, Galway City, Quality Engineer	Galway	Not Disclosed
Quality Specialist Job title: Quality Assurance Specialist Location: Western Business Park, Shannon, Co. Clare Benefits: Good salary, Healthcare, pension, 25 days holidays, opportunity to grow your career with exciting Medical Device company working on projects from concept. Summary: The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System with my Medical Device client in order to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements. The QMS includes m... Location: Clare, Limerick, Limerick City, Republic of Ireland, Quality Specialist	EU	Not Disclosed
Quality Specialist Job title: Quality Assurance Specialist Location: Western Business Park, Shannon, Co. Clare Benefits: Good salary, Healthcare, pension, 25 days holidays, opportunity to grow your career with exciting Medical Device company working on projects from concept. Summary: The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System with my Medical Device client in order to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements. The QMS includes m... Location: Clare, Limerick, Limerick City, Republic of Ireland, Quality Specialist	EU	Not Disclosed
Quality Specialist Job title: Quality Assurance Specialist Location: Western Business Park, Shannon, Co. Clare Benefits: Good salary, Healthcare, pension, 25 days holidays, opportunity to grow your career with exciting Medical Device company working on projects from concept. Summary: The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System with my Medical Device client in order to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements. The QMS includes m... Location: Clare, Limerick, Limerick City, Republic of Ireland, Quality Specialist	EU	Not Disclosed
Quality Engineer Role: Quality Engineer Location: Carrick on Shannon, Leitrim Benefits: Competitive salary, Bonus, pension, healthcare and hybrid working Company: Work with theLargest employer in Leitrim show specialise in making Catheters all inhouse. Work in a company have cleanrooms dedicated to customers, very specialised. Generally have about 100 promotions per year – Projects involved, individual plans, goal setting, leadership training. Responsibilities Assist with the implementation and development of the site QMS in line with the ... Location: Athlone, Connaught, Leitrim, Longford, Midlands, Quality Engineer	EU	Not Disclosed
Senior Quality Engineer Role: Senior Quality Engineer Location: Carrick on Shannon, Leitrim Benefits: Competitive salary, Bonus, pension and healthcare Company: Work with theLargest employer in Leitrim show specialise in making Catheters all inhouse. Work in a company have cleanrooms dedicated to customers, very specialised. Generally have about 100 promotions per year – Projects involved, individual plans, goal setting, leadership training. Responsibilities Integration & Maintenance of the Quality Management System with all Freudenberg Medi... Location: Leitrim, Longford, Midlands, Roscommon, Sligo, Senior Quality Engineer	EU	Not Disclosed
Senior Quality Engineer Role: Senior Quality Engineer Location: Carrick on Shannon, Leitrim Benefits: Competitive salary, Bonus, pension and healthcare Company: Work with theLargest employer in Leitrim show specialise in making Catheters all inhouse. Work in a company have cleanrooms dedicated to customers, very specialised. Generally have about 100 promotions per year – Projects involved, individual plans, goal setting, leadership training. Responsibilities Integration & Maintenance of the Quality Management System with all Freudenberg Medi... Location: Leitrim, Longford, Midlands, Roscommon, Sligo, Senior Quality Engineer	EU	Not Disclosed
Senior Quality Engineer Role: Senior Quality Engineer Location: Carrick on Shannon, Leitrim Benefits: Competitive salary, Bonus, pension and healthcare Company: Work with theLargest employer in Leitrim show specialise in making Catheters all inhouse. Work in a company have cleanrooms dedicated to customers, very specialised. Generally have about 100 promotions per year – Projects involved, individual plans, goal setting, leadership training. Responsibilities Integration & Maintenance of the Quality Management System with all Freudenberg Medi... Location: Leitrim, Longford, Midlands, Roscommon, Sligo, Senior Quality Engineer	EU	Not Disclosed
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 Systems Manager Company: 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, Quality Systems Manager	EU	Not Disclosed
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

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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.