Job Title.	Location	Salary	Actions
Supplier Quality Manager Our client a medical device multinational currently seeks a Supplier Quality Manager to join their team. Supplier quality Manager is directly accountable for managing Supplier Quality engineering functions across multiple sites in North America & EMEA. The role will include staffing, developing, and managing a Supplier Quality Engineering team to effectively support and execute supplier qualifications, supplier maintenance, quality agreements, supplier auditing, SCARs, and supplier-driven changes. Additionally, this role will drive initiatives for optimization of Qua... Location: Westmeath, Supplier Quality Manager	Westmeath	Not Disclosed
NPI Quality Engineering Manager NPI Quality Engineering Manager Our client a medical device multinational are currently seeking a NPI Quality Engineering Manager on 2-Year Fixed Term Contract to join their team. 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 ISO134... Location: Dublin, NPI Quality Engineering Manager	Dublin	Not Disclosed
Quality & Compliance Manager Life Science Recruitment are currently working with our client, a relateively new beverages company with a difference. The Role Our client currently delivers to consumers through an outsourced manufacturing and co-packing model and use a variety of distributors to get their product to market via the relevant supply channels. Reporting to the Global Operations Director, the Quality & Compliance Manager will be a key member of the Global Operations team with overall QMS and regulatory oversight for each of the international markets we operate in. If you are interested in working... Location: Kildare, Quality & Compliance Manager	Kildare	Not Disclosed
Quality Manager Our client a Dublin based Medical Deviceorganization, are currently seeking a Quality Manager to join their team. Reporting to the Head of Quality and Regulatory Affairs the Quality Manager will lead, manage and grow a team, be required to liaise with regulatory notified bodies and can operate within a small company environment Role/Responsibilities: Responsible for the implementation and maintenance of the Quality Management System in line with applicable regulatory requirements including EN ISO 13485:2016, MDD 93/42/EEC, MDR ... Location: Dublin, Quality Manager	Dublin	Not Disclosed
Senior Quality and Regulatory Manager Senior Quality & Regulatory Manager Our client a growing Irish Med Tech company who have developed a technology that changes peoples lives currently seeks a Senior Quality and Regulatory Manager to join their team. The Senior Quality and Regulatory Manager will be required to lead the company wide Quality Management system ensuring they meet design specifications and standards for products and services. The role also has responsibility for regulatory clearance and compliance in target and existing markets, as well as providing technical support and guid... Location: Galway, Senior Quality and Regulatory Manager	Galway	Not Disclosed
QA Manager Our client a high potential start up is looking to hire a Quality Manager who will lead the Quality activities to bring a cutting edge through design development, verification, clinical trials, validation and regulatory approval. This role will provide Quality leadership to meet objectives in the development, implementation and maintenance of a robust and fully compliant Quality System. This position offers the opportunity to join the management team in an exciting early stage company. Role/Responsibilities Development, implementation and maintenance of a robust and f... Location: Dublin, QA Manager	Dublin	Not Disclosed
Quality Systems Manager Our client a high potential medical device start up are currently seeking a Quality Systems Manager to join their team. The Quality Systems Manager , you will provide hands-on leadership to the rest of the organisation in terms of quality systems, knowledge, compliance and training.Successful candidate will provide strategic project direction and ensure that regulations, standards and requirements as implemented are up-to-date, identify compliance gaps and take action to address them. Role/Responsibilities: ... Location: Galway, Quality Systems Manager	Galway	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

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Supplier Quality Manager

NPI Quality Engineering Manager

Quality & Compliance Manager

Quality Manager

Senior Quality and Regulatory Manager

QA Manager

Quality Systems Manager

Quality Manager Career Profile

Quality Manager