close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome		 IE
Internet Explorer		 firefox
Mozilla Firefox		 opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Search Results for Quality Manager
Job Title. Location Salary Actions

Quality and Regulatroy Manager

QUALITY & REGULATORY MANAGER Our client an indigenous Irish medical device company who has recently undergone significant investment are currently seeking a Quality and Regulatory Manager to join their team. Reporting to executive leadership the Quality and Regulatory Manager will have a proven ability to lead the quality assurance agenda across the company, possess knowledge of regulatory processes for EU and FDA product clearance, demonstrate excellent people and team management skills and experience of quality management in the context of R&D and design ...

Location: Galway,
Quality and Regulatroy Manager 		Galway 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
Subscribe RSS feed for this search

Quality Manager Career Profile

Quality Manager


This is a wide role which often requires a Medical Device Quality Systems background and expertise within ISO 13485. Applyling this knowledge to a cutting edge industry is often an attraction for candidates who are used to working in a more manufacturing-orientated environment. A sample spec is below:

Key Responsibilities


  • Initially as a core member of the team which will implement a Global Quality Management System,
  • As required oversee the production of DHF for products to be marketed in the US.
  • As required assist in the preparation of 510k submissions for our client's products and product components. This may also require some involvement in clinical trials.
  • As required develop an understanding of other overseas regulatory requirements (and prepare for submissions where clearance is required.
  • Proactively develop and maintain the Company Quality Management System in accordance with regulatory and corporate requirements.
  • Furthermore seek to improve the efficiency and effectiveness of the Quality System to meet the business strategy of the company.
  • Act as the company representative in any company inspections/audits.
  • Under the direction of the Head of RA/QA take ownership for the co-ordination of specific
  • projects providing specific regulatory and quality services.
  • Oversee design control for specific company products: review and approval of documents,
  • maintain design history file, communicate findings and suggestion for improvements to design group. Ensure documents are produced in accordance with company procedures and check all documents for consistency and accuracy prior to issue.
  • Work with service/manufacturing to ensure adequate quality controls prior to shipping.

Qualifications / Experience

  • Degree level qualification preferred or an equivalent combination of education and experience to operate at this level.
  • Proven RA / QA experience supporting product design control, customer support and production with at strong supervisory experience.
  • Working knowledge of FDA Quality Systems Regulations and ISO 13485:2003 required.
  • Internal audit qualification also preferred. ISO13485 lead auditor qualification preferred but not essential.
  • Experience in medical devices
  • Understanding of QA and Regulatory requirements