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Search Results for Quality Manager
Job Title. Location Salary Actions

Qualified Person QP

Qualified Person QP Our Dublin based client are currently recruiting for a Qualified Person to join their team. This is a permanent opportunity and the ideal

Location: Dublin,
Qualified Person QP
Dublin Not Disclosed

Senior Manager Product QA

Senior Manager, Product QA Our client, a global biopharmaceutical organisation based in Sligo, are currently recruiting for a Senior Manager, Product QA to join their team on a permanent basis. As Senior Manager you will to lead a technical team of 6 experienced Quality and Regulatory professionals, including 3 QPs. The successful candidate will be responsible for the release of all finished products from the site across API and Drug Product. Responsibilities: • Managing the QP and Regulatory group, including batch release, product performance, new products ...

Location: Sligo,
Senior Manager Product QA
Sligo Not Disclosed

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

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
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Training Coordinator Galway Not Disclosed
Administration Support Dublin North 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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