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Search Results for Quality Manager
Job Title. Location Salary Actions

Quality/Commissioning Lead

Our client is an innovative organization who designs & manufacture clean room solutions for the Pharma & Biopharma industries. They have offices & manufacturing capabilities in both the US & Ireland. They are seeking a Quality Lead for their manufacturing in Kilkenny in Ireland. The successful person shall be involved in all inspection, testing, and commissioning activities throughout the product design, manufacturing and testing phases. The Quality lead will be responsible for following company procedures to ensure that our client provides a consistent...

Location: Kilkenny,
Quality/Commissioning Lead
Kilkenny Not Disclosed

Director of Quality Risk Management System

Director of Quality Risk Management System Our client, a leading biotech organisation are currently recruiting for a Director Quality Risk Management System.

Location: Limerick,
Director of Quality Risk Management System
Limerick Not Disclosed

Senior Source Quality Engineer

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Cork . The Senior Source Quality Engineer is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Travel Opportunities: EU based travel may be required. Your duties: Provide overall quality assurance leadership in the management of suppliers engaged in the production of products. Provide complex product team support for quality system design and audit, compliance assessment%...

Location: Cork,
Senior Source Quality Engineer
Cork Not Disclosed
Other Connected Health Jobs
Job Title Location Salary Actions
Associate Manager (Technical Training) Limerick Not Disclosed

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