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Search Results for Quality Manager
Job Title. Location Salary Actions

Quality Manager (Healthcare)

Our client is an indigenous Pharmaceutical organisation based in Dublin who sell & distribute healthcare products across Ireland & the UK. They are currently seeking an experienced Quality Manager who will be responsible for managing the processes and systems to ensure that the company is in compliance with all applicable regulatory and business requirements. Role/Responsibilities: • Lead our clients Quality Management Systems including Documentation, Complaints Management, CAPA and Management Review. • The Quality Manager is responsible for ov...

Location: Dublin,
Quality Manager (Healthcare)
Dublin Not Disclosed

Associate Director QA Medical Devices

Our client a multinational biotech company and currently seeking an Associate Director of QA for their Medical Device/Combination Products. The Associate Director will Provide QA oversight of the Medical Device/Combination Products including pre-filled syringe and auto-injectors/pen injectors for biological therapeutics developed in-house and in collaboration with partners and CMO’s. Supports the work of Industrial Operations and Product Supply (IOPS) sites through the use of quality risk management principles and their application to medical device development and comme...

Location: Limerick,
Associate Director QA Medical Devices
Limerick Not Disclosed

Associate Director Quality Risk Management System

Associate Director Quality Risk Management System Our client, a leading biotech organisation are currently recruiting for an Associate Director Quality Risk Management System. As Associate Director Quality Risk Management System you will be global process owner of the end to end Global Quality Risk Management System across global functions at sites, including combination product development, Drug substance and drug product clinical and commercial production. You will be responsible for ensuring adoption of Risk Management principals is applied across disciplines and lifecycle throu...

Location: Limerick,
Associate Director Quality Risk Management System
Limerick Not Disclosed

Senior Quality Engineer

Senior Quality Engineer The Senior Design Assurance Engineer is accountable for quality support for products developed and process design to achieve these goals through active participation and contribution to multifunctional and multi-divisional teams. The Senior Design Assurance Engineer is responsible for assuring that quality standards and regulatory compliance activities are consistent with Corporate/Division Policies, Government Regulations, International Standards and standards broadly recognized by the Medical Device Industry. The position requires a self-motivated, self-d...

Location: Limerick,
Senior Quality Engineer
Limerick 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
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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