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Clinical Project Manager
Republic of Ireland
VP of R&D
Galway
R&D Manager
Galway
Process Engineer
Dublin North
Data Scientist
Limerick
Quality Engineer
Limerick
Process Engineer
Limerick
GMP Inspector
Dublin
Senior GMP Auditor
Republic of Ireland
Process Engineer
Limerick
Principal R&D Engineer
Dublin Greater
Consultant
James Cassidy
Life Science

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

Quality, Safety & Risk Manager

Quality, Safety & Risk Manager Our Dublin based client are currently recruiting for a Quality, Safety & Risk (QSR) Manager who will support the design, implementation, monitoring and review of the Quality, Safety & Risk (QSR) framework. The framework will underpin the development of a robust standardised, accredited patient safety model which underpins the delivery of efficient, effective safe services and an excellent patient experience within a financially sustainable delivery model. The role holder will play a key role in designing and i...

Location: Dublin,
Quality, Safety & Risk Manager
Dublin Not Disclosed

Health Products Distribution Inspector

Health Products Distribution Inspector Our client, a large regulatory body are currently recruiting for a Health Products Distribution Inspector to join their team. As Health Products Distribution Inspector you will be responsible for assessing the compliance of a wide range of national operators involved in certain activities of the pharmaceutical, cosmetic, chemical and medical device industries Responsibilities Responsible for assessing the compliance of a wide range of national operators involved in certain activities of the pharmaceutical, cosmetic, chemical and m...

Location: Dublin,
Health Products Distribution Inspector
Dublin Not Disclosed

NPI Quality Manager

Our client a multinational medical device company are currently seeking a NPI Quality Engineer to join their team. Reporting to Senior Quality Engineering Manager the NPI Quality Manager will play a pivotal role in site process improvement activities and be the central point of contact for key customers. Duties will include management and approval of process validation studies, project management, application of SPC to current production processes and liaison with key partners. Role/Responsibilities Providing support for ISO13485 Quality System. Ensuring alignment...

Location: Dublin,
NPI Quality Manager
Dublin Not Disclosed

Manager/Senior Manager QA Operations

Manager/Senior Manager QA Operations Our client, a growing Biopharma organisation are currently recruiting for a Manager/Senior Manager QA Operations to join their team on permanent basis. As Manager/Senior Manager QA Operations you will beresponsible for overseeing a QA team and their projects. Responsibilities Responsible for all aspects of QA Team including review and approval of the following types of documents, relating to area functions; Master records, executed records, failure investigations Change Controls, SOPs, Validation protocols and summary re...

Location: Limerick,
Manager/Senior Manager QA Operations
Limerick Not Disclosed

Quality and Regulatory Affairs Manager

Quality & Regulatory Affairs Manager Our client, a leading healthcare organisation are currently recruiting for a Quality and Regulatory Affairs Manager to join their team on a permanent basis. As Quality & Regulatory Affairs Manager you will be responsible for leading the regulatory affairs and quality assurance functions within the organisation. You will manage the department effectively to ensure compliance, continuous improvement and to ensure product quality and customer satisfaction. Responsibilities Provide Quality & Regulatory ...

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