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Search Results for Quality Specialist
Job Title. Location Salary Actions

Medical Device Inspector

Medical Device Inspector Our Client an Irish Regulatory Body requires a Medical Device Inspector to join their Medical Device Compliance Team. Responsibilities • Plan and conduct proactive and reactive audits of manufacturers and other economic operators as part of the market surveillance activities for medical devices • Execution of audits relating to designation of notified bodies for medical devices in Ireland and as part of European joint assessment activities • Execution of audits arising from ongoing surveillance and monitoring programme for Notified...

Location: Dublin,
Medical Device Inspector
Dublin Not Disclosed

QA Specialist

QA Specialist - Cork Reporting to: Head of Quality Department: Quality Purpose of Role To prepare, maintain, update and archive all Quality documentation at the company. Ensure relevant documentation is in place to support any quality/manufacturing activity Highlight any GMP oversights or issues Provide QA support to relevant personnel on how to address any GMP issues as required Follow up to ensure that any GMP issues are addressed appropriately Coach/train relevant personnel on quality issues and provide feedback as necessary Assist with...

Location: Cork City,
QA Specialist
Cork City Not Disclosed

Quality Consultant/Manager

Quality Consultant/Manager-Fully remote working Our client a pharmaceutical consulting organisation are currently recruiting for a Quality Consultant/Manager to join their team on a permanent basis. As Quality Consultant/Manager you will be responsible for providing key support to the Director/Senior Consultant in all matters relating to the provision of services to clients and customer base. This is 100% remote working. Responsibilities Liaise with customers with regard to their requirements, determining their needs and timelines and to manage client projects inclu...

Location: Republic of Ireland,
Quality Consultant/Manager
Republic of Ireland Not Disclosed

QA Representative/Specialist

Life Science Recruitment are currently working with our Cork based pharmaceutical client to source a QA Representative to join their team in Little Island. Reporting to the QA Lead this role will support the implementation, maintenance and operations of the Quality systems for the Global Business Solutions center. For the Global Business Solutions Center you will support and manage GMP compliance and GDP (Good Distribution Practice) activities and GMP decisions on Products and Quality issues in conjunction with the appropriate Affiliate Product Quality Rep...

Location: Cork,
QA Representative/Specialist
Cork Not Disclosed

Senior QA Engineer

Senior QA Engineer Our client a high potential medical device company currently seeks a Senior QA Engineer to join their team. Reporting to the QA/RA Manager the Senior QA Engineer will support the product development of a cutting-edge device through design development, verification, clinical trials, validation and regulatory approval. Role/Responsibilities • Working as a part of a cross-functional team to design and develop a device in line with user needs • Demonstrating and promoting a commitment to improving patient safety, custo...

Location: Dublin,
Senior QA Engineer
Dublin Not Disclosed
Other Quality Assurance Jobs
Job Title Location Salary Actions
Quality Director Dublin Not Disclosed
Quality Director Dublin Not Disclosed
Account Technical Manager (Food & Beverage - Leinster) Dublin Not Disclosed
Quality Assurance Specialist Cork Not Disclosed
Senior Quality Systems Engineer Galway Not Disclosed
QA Specialist Cork Not Disclosed
Account Technical Manager (Food & Beverage - Leinster) Dublin Not Disclosed
QA Specialist Cork 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.