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Search Results for Quality Manager
| Job Title. | Location | Salary | Actions |
Quality Assurance ManagerJob title: Quality Manager Location: Galway Benefits: Top salary, Bonus, pension, healthcare Company: My client are a Medical device manufacturer with a new hub in Galway. They specialise in catheters, medical balloons, EM-Micro Sensors, engineered shafts, and complete device assemblies, supporting a wide range of interventional therapies. Responsibilities: Ensure the QMS processes and documentation are established, implemented, and maintained in compliance with ISO 13485, ISO 9001, and 21 CFR Part 820. Promote awar...Location: Galway, Galway City, |
Galway | Not Disclosed | |
NPD Quality ManagerJob title: Quality Manager Location: Galway Benefits: Top salary, Bonus, pension, healthcare Company: My client are a Medical device manufacturer with a new hub in Galway. They specialise in catheters, medical balloons, EM-Micro Sensors, engineered shafts, and complete device assemblies, supporting a wide range of interventional therapies. Responsibilities: Ensure the QMS processes and documentation are established, implemented, and maintained in compliance with ISO 13485, ISO 9001, and 21 CFR Part 820. Promote awar...Location: Galway, Galway City, |
Galway | Not Disclosed | |
Quality ManagerJob title: Quality Manager Location: Galway Benefits: Top salary, Bonus, pension, healthcare Company: My client are a Medical device manufacturer with a new hub in Galway. They specialise in catheters, medical balloons, EM-Micro Sensors, engineered shafts, and complete device assemblies, supporting a wide range of interventional therapies. Responsibilities: Ensure the QMS processes and documentation are established, implemented, and maintained in compliance with ISO 13485, ISO 9001, and 21 CFR Part 820. Promote awarene...Location: Galway, Galway City, |
Galway | Not Disclosed | |
Quality ManagerJob title: Quality Manager Location: Galway Benefits: Top salary, Bonus, pension, healthcare and 4 day working week. Company: My client are a Medical device manufacturer with a new hub in Galway. They specialise in catheters, medical balloons, EM-Micro Sensors, engineered shafts, and complete device assemblies, supporting a wide range of interventional therapies. Responsibilities: Act as the Management Representative for the Quality Management System (QMS). Ensure the QMS processes and documentation are established, ...Location: Galway, Galway City, |
Galway | Not Disclosed | |
Quality ManagerJob title: Quality Manager Location: Galway Benefits: Top salary, Bonus, pension, healthcare and hybrid. Company: My client are a Medical device manufacturer with a new hub in Galway. They specialise in catheters, medical balloons, EM-Micro Sensors, engineered shafts, and complete device assemblies, supporting a wide range of interventional therapies. Responsibilities: Act as the Management Representative for the Quality Management System (QMS). Ensure the QMS processes and documentation are established, implemented, ...Location: Galway, Galway City, |
Galway | Not Disclosed | |
Quality ManagerJob title: Quality Manager Location: Galway Benefits: Top salary, Bonus, pension, healthcare and 4 day working week. Company: My client are a Medical device manufacturer with a new hub in Galway. They specialise in catheters, medical balloons, EM-Micro Sensors, engineered shafts, and complete device assemblies, supporting a wide range of interventional therapies. Responsibilities: Act as the Management Representative for the Quality Management System (QMS). Ensure the QMS processes and documentation are established, imp...Location: Galway, Galway City, |
Galway | Not Disclosed | |
Senior Quality EngineerJob title: Senior Quality Engineer Location: Glasnevin, Dublin 11 Benefits: Top salary, Bonus, pension and Healthcare Company: An exciting time for my client who are currently running clinical trials across Europe and the US, in collaboration with leading researchers and scientists who share our commitment to transforming the lives of the millions of people living with heart failure. They have a diverse team who respect each other’s opinions and work and learn together in an open and honest way to achieve their ambitious purpose. Job Overview: ...Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South, |
EU | Not Disclosed | |
Senior Quality EngineerJob title: Senior Quality Engineer Location: Glasnevin, Dublin 11 Benefits: Top salary, Bonus, pension and Healthcare Company: An exciting time for my client who are currently running clinical trials across Europe and the US, in collaboration with leading researchers and scientists who share our commitment to transforming the lives of the millions of people living with heart failure. They have a diverse team who respect each other’s opinions and work and learn together in an open and honest way to achieve their ambitious purpose. Job Overview: ...Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South, |
EU | Not Disclosed | |
Senior Quality EngineerJob title: Senior Quality Engineer Location: Glasnevin, Dublin 11 Benefits: Top salary, Bonus, pension and Healthcare Company: An exciting time for my client who are currently running clinical trials across Europe and the US, in collaboration with leading researchers and scientists who share our commitment to transforming the lives of the millions of people living with heart failure. They have a diverse team who respect each other’s opinions and work and learn together in an open and honest way to achieve their ambitious purpose. Job Overview: ...Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South, |
EU | Not Disclosed | |
Senior Quality EngineerTitle: Senior Quality Engineer Location: Dublin 1 (Hybrid working) Company: My client are developing a Best-In-Class minimally invasive solution for severe Tricuspid Regurgitation (TR).It is a clear unmet clinical need, with a significant impact on mortality, cardiovascular events and quality of life. With a prevalence greater than aortic stenosis in the population over 65 years, TR is the next structural heart opportunity. Responsibilities: Support the development, implementation, and maintenance of the QMS in accordance with relevant st...Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South, |
EU | Not Disclosed | |
Quality Systems ManagerCompany: My client are have a global portfolio which includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. They are committed to helping create healthier communities worldwide through education, outreach and better access to treatment Role: Quality Systems Manager - Senior Location: Newenham Court, Northern Cross, Malahide rd, Dublin 17 Team: 6 direct reports Hybrid working: 2-3 days a week on site per week Benefits: Compe...Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South, |
EU | Not Disclosed | |
Senior Quality EngineerTitle: Senior Quality Engineer Location: Dublin 1 (Hybrid working) Company: My client are developing a Best-In-Class minimally invasive solution for severe Tricuspid Regurgitation (TR).It is a clear unmet clinical need, with a significant impact on mortality, cardiovascular events and quality of life. With a prevalence greater than aortic stenosis in the population over 65 years, TR is the next structural heart opportunity. Responsibilities: Support the development, implementation, and maintenance of the QMS in accordance with relevant st...Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South, |
EU | 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
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Understanding of QA and Regulatory requirements