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Search Results for Quality Manager
Job Title. Location Salary Actions

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

Senior Quality Manager

Senior Quality Manager Our client a high potential start up are seeking a Senior Quality Manager to join their team. Reporting to the Director of Quality and Regulatory the Senior Quality Manager will have a minimum of eight years’ experience in a similar role in the medical device sector. The Senior Quality Manager will work with a cross functional team providing both quality and technical input to ongoing product development and post market commercial product activities. This role will offer you the flexibility to work both in on site and from home. ...

Location: Dublin,
Senior Quality Manager
Dublin Not Disclosed

Supplier Quality Manager

Our client a medical device multinational currently seeks a Supplier Quality Manager to join their team. Supplier quality Manager is directly accountable for managing Supplier Quality engineering functions across multiple sites in North America & EMEA. The role will include staffing, developing, and managing a Supplier Quality Engineering team to effectively support and execute supplier qualifications, supplier maintenance, quality agreements, supplier auditing, SCARs, and supplier-driven changes. Additionally, this role will drive initiatives for optimization of Qua...

Location: Westmeath,
Supplier Quality Manager
Westmeath 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