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Search Results for Quality Manager
Job Title. Location Salary Actions

Quality Assurance and Regulatory Affairs Manager

Quality Assurance and Regulatory Affairs Manager Our client, one of the largest biomedical innovator based in Dublin is looking to recruit QA/RA Manager wh

Location: Dublin North,
Quality Assurance and Regulatory Affairs Manager
Dublin North Not Disclosed

Analytical Scientist Level III

Analytical Scientist Level III Our client, one of the largest multinational companies based in Galway is recruiting for Analytical Scientist. The successful candidate will perform wet chemistry and chromatographic testing of development samples, raw materials, finished product, stability samples, and formulation samples for existing products or products under development with trending of data in a diligent and timely manner to support regulatory submissions. The Position • Carry out wet chemistry and chromatographic analytical method development with guidance%2...

Location: Galway,
Analytical Scientist Level III
Galway Not Disclosed

Senior Supplier Quality Engineer

Senior Supplier Quality Engineer Our client, one of the largest multinational company based in UK is recruiting for Senior Supplier Quality Engineer. The role is responsible for the coordination and implementa-tion of on-site and documentation audits, related observations, NCs, CAPAs and communication of evaluation results to key stakeholders. Provide cross-functional supplier au-diting services to R&D, Acquisition, Manufacturing, Materials, Purchasing, and Opera-tions stakeholders worldwide. The Position • Drive continuous improvement within the S...

Location: United Kingdom,
Senior Supplier Quality Engineer
United Kingdom Not Disclosed

Associate Group Leader, Inhalation

Associate Group Leader, Inhalation Our client, one of the largest Contract Research Organizations in Athlone is recruiting for Associate Group Leader (Inhalation) . The successful candidate will Provides line-level management coordination of resources and work schedules for laboratory activities. Oversees daily operations and assists in preparation and implementation of company policies, quality systems and training programs. Ensures that projects are completed in a timely manner so that company revenues are met and clients are satisfied with the quality and turnaround time of...

Location: Westmeath,
Associate Group Leader, Inhalation
Westmeath Not Disclosed

QA Manager

Our client is a service-provider-of-choice to the pharma and biotech industries in Ireland and internationally. They are seeking an adaptable, skilled and flexi

Location: Meath,
QA Manager
Meath Not Disclosed
Other Connected Health Jobs
Job Title Location Salary Actions
Administration Support Dublin North Not Disclosed
Training Coordinator Galway 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
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