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QA Manager Biologics
Dublin West
Risk Manager
Dublin
Consultant
Cork
CTO
Galway
R&D Engineer
Galway
Program Manager
Westmeath
QA Manager
Dublin West
Snr QA Specialist
Dublin South
QC Manager
Dublin
QA Manager
Meath
R&D Engineer
Dublin
National Sales Representative
Republic of Ireland
QA Manager
Dublin North
Administration Support
Dublin North
Supply Chain Analyst
Dublin North
Biostatistician
Dublin City Centre
API Purchaser
Dublin
Quality Assurance Manager
Republic of Ireland
QA Manager
Dublin
Consultant
James Cassidy
Life Science

+353 1 5079250
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Search Results for Quality Manager
Job Title. Location Salary Actions

Quality Assurance Manager

Quality Assurance Manager Life Science Recruitment are sourcing a Quality Assurance Manager to lead the Quality Team at a global medical device manufacturing

Location: Republic of Ireland,
Quality Assurance Manager
Republic of Ireland €80000 - €100000

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

Senior Quality Engineer

SENIOR QUALITY ENGINEER Our Client, One of the largest medical device companies based in Galway is currently recruiting Senior Quality Engineer . The successful candidate will lead and work as part of a team to maintain high quality and performance standards on all Medical products. Reporting to the Operations Quality Manager, the position will be challenging and will require an ability to lead a team and work on own initiative and with minimum supervision. The Role • Lead and drive QA initiatives within area of functional responsibility. • Provide quality inpu...

Location: Galway,
Senior Quality Engineer
Galway Not Disclosed

Head of Quality & Regulatory Affairs

Head of Quality & Regulatory Affairs Our client a multinational healthcare company currently seeks Head of Quality and Regulatory Affairs. Reporting to Ge

Location: Dublin,
Head of Quality & Regulatory Affairs
Dublin Not Disclosed

GES Performance Excellence Manager

Our client is a global pharmaceutical multinational based in Dublin, who is seeking Global External Supply Excellence Manager to join their team. After investin

Location: Dublin West,
GES Performance Excellence Manager
Dublin West 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

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