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Validation Engineer
Cork
Cork
Associate Scientist - Analytical Attribu
Dublin South
Dublin South
Process Engineer
Galway
Galway
Biomedical Engineer
Dublin
Dublin
Quality Systems Enginer
Dublin
Dublin
Process Support Specialist
Carlow
Carlow
Manufacturing Engineer
Wexford
Wexford
Qualified Person - Biotech
Limerick City
Limerick City
Senior Quality Engineer
Galway
Galway
Maintenance Engineer
Carlow
Carlow
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Senior R&D Engineer
Clare
Clare
Recruitment Consultant
Wexford
Wexford
Principal R&D Engineer
Dublin
Dublin
Warehouse Operator (Shift)
Carlow
Carlow
Senior R&D Engineer
Dublin
Dublin
Senior R&D Engineer-New Product Deve
Westmeath
Westmeath
Project Engineer
Limerick
Limerick
Engineering Manager
Clare
Clare
Manufacturing Engineer
Galway
Galway
Maintenance Engineer
Cork
Cork
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Program Manager
Cork
Cork
Project Engineer
Clare
Clare
Project Engineer
Republic of Ireland
Republic of Ireland
R&D Director
Galway
Galway
Project Engineer
Limerick
Limerick
Manufacturing Engineer
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Associate Quality Specialist
Tipperary
Tipperary
QA Associate
Cavan
Cavan
Quality Technician
Carlow
Carlow
Manufacturing Engineer
Limerick
Limerick
Electronic Design Engineer
Galway
Galway
Responsible Person (RP)
Republic of Ireland
Republic of Ireland
Senior Electrical Engineer
Galway
Galway
Quality Manager
Dublin
Dublin
Technical Support Scientist
Longford
Longford
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Senior Quality Engineer
Dublin
Dublin
E&I Turnover Engineer
Carlow
Carlow
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Product Development Engineer
Galway
Galway
QA Specialist
Cork
Cork
Validation Engineer
Limerick
Limerick
Quality Engineer
Wexford
Wexford
Engineering Shift Technician
Dublin
Dublin
R&D Manager
Galway
Galway
Change Control Coordinator
Carlow
Carlow
Validation Engineer
Carlow
Carlow
Engineering Projects Lead
Carlow
Carlow
QC Bioassay Analyst (shift)
Carlow
Carlow
Biomedical Engineer
Dublin
Dublin
C&Q Lead
Tipperary
Tipperary
Quality Engineer
Athlone
Athlone
Senior R&D Project Manager
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
Operations Specialist
Louth
Louth
Process Engineer
Cork
Cork
R&D Director
Galway
Galway
Principal R&D Engineer
Galway
Galway
Production Operator
Carlow
Carlow
Biomedical Engineer
Dublin
Dublin
Senior QC Associate
Dublin
Dublin
Product Development Engineer
Galway
Galway
Project Engineer
Carlow
Carlow
Distribution Centre Manager
Dublin
Dublin
Senior Validation Engineer
Dublin
Dublin
Quality Systems Specialist
Galway
Galway
Senior Validation Engineer
Limerick
Limerick
QC Analyst
Cavan
Cavan
Project Manager - Suite Lead
Tipperary
Tipperary
R&D Manager
Galway
Galway
Maintenance CMMS Engineer
Tipperary
Tipperary
Senior Regulatory Affairs Specialist
Westmeath
Westmeath
Aseptic Process Lead
Carlow
Carlow
R&D Director
Galway
Galway
QC Chemistry Analyst (Shift)
Carlow
Carlow
Microbiology Manager
Dublin
Dublin
Process Engineer (Shift)
Carlow
Carlow
Product Development Engineer
Galway
Galway
Packaging Engineer
Dublin
Dublin
Medical Device Director
Republic of Ireland
Republic of Ireland
Clinical Affairs Manager
Galway
Galway
Senior R&D Engineer
Galway
Galway
Quality Manager
Dublin
Dublin
Senior QC Associate
Dublin
Dublin
R&D Program Manager
Dublin
Dublin
R&D Manager
Galway
Galway
Analytical Scientist (hybrid)
Tipperary
Tipperary
Project Process Engineer
Carlow
Carlow
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Engineering Business Manager
Dublin
Dublin
Senior R&D Manager/Director
Dublin
Dublin
Recruitment Consultant
Republic of Ireland
Republic of Ireland
E&I Turnover Engineer
Carlow
Carlow
Trainer
Dublin
Dublin
Process Support Specialist
Carlow
Carlow
R&D Manager
Galway
Galway
Strategic Automation Lead
Waterford
Waterford
Quality Engineer
Athlone
Athlone
Manufacturing Technician
Clare
Clare
Quality Manager - NPI
Dublin
Dublin
Senior R&D Engineer
Clare
Clare
Quality Specialist
Tipperary
Tipperary
Senior Manufacting Engineer
Republic of Ireland
Republic of Ireland
Senior Electronics Engineer
Dublin
Dublin
Senior QC 24/7 Shift
Dublin
Dublin
Biostatistician
Cork
Cork
Maintenance CMMS Engineer
Tipperary
Tipperary
Principal QA Associate
Limerick
Limerick
Director of Quality Engineering
Limerick
Limerick
Senior Quality Engineer
Dublin
Dublin
Pharmaceutical Consultant RP/RPi
United Kingdom
United Kingdom
Aseptic Process Owner Lead
Dublin
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Senior Regulatory Affairs
Galway
Galway
Senior Technical Writer
Dublin
Dublin
Project Manager - R&D
Galway
Galway
Associate Global Trade Ops
Dublin
Dublin
Product Development Engineer
Galway
Galway
Senior Quality Engineer
Limerick
Limerick
Process Engineer
Limerick
Limerick
Senior Mechanical Engineer
Dublin
Dublin
Senior Quality Engineer-Remote
Republic of Ireland
Republic of Ireland
Senior Engineering Manager
Limerick
Limerick
Quality Systems Manager
Dublin
Dublin
QC Laboratory Technician
Carlow
Carlow
Sourcing Specialist
Tipperary
Tipperary
Senior Quality Engineer
Dublin
Dublin
Maintenance Reliability Engineer
Tipperary
Tipperary
Principal Process Equipment Engineer
Dublin South
Dublin South
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Quality Manager - NPI
Dublin
Dublin
Digital Lab Records Specialist
Tipperary
Tipperary
Facilities Engineer
Carlow
Carlow
Occupational Hygiene Consultant
Kildare
Kildare
R&D Engineer
Dublin
Dublin
EHS Project Lead
Cavan
Cavan
Senior Mechanical Engineer
Dublin
Dublin
Process Development Engineer
Galway
Galway
Head of R&D
Galway
Galway
Embedded Software Engineer
Dublin
Dublin
Quality Manager
Clare
Clare
Senior Validation Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Principal R&D Engineer
Galway
Galway
QA Associate - Materials Management
Limerick
Limerick
Senior R&D Engineer
Galway
Galway
R&D Senior Program Manager
Galway
Galway
Clean Utilities Engineer
Carlow
Carlow
Project Manager
Limerick
Limerick
Senior Electronic Engineer
Dublin
Dublin
Process Support Specialist
Carlow
Carlow
Clean Utilities Engineer
Carlow
Carlow
Electrical Engineer
Cork
Cork
Principal R&D Engineer
Dublin
Dublin
Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
Quality Validation Engineer
Limerick
Limerick
Electrical Engineer
Limerick
Limerick
Senior Validation Engineer
Limerick
Limerick
Chemical Engineer
Tipperary
Tipperary
Senior Quality Engineer
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
Product Development Engineer
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Suite Team Delivery Lead
Tipperary
Tipperary
QA Associate Specialist
Carlow
Carlow
Senior Electronic Engineer
Dublin
Dublin
Senior QA Associate - Operations
Limerick
Limerick
CQV Lead
Tipperary
Tipperary
Technical Specialist
Cork
Cork
Senior R&D Engineer
Galway City
Galway City
Production Operator
Carlow
Carlow
Specialist Operations Engineer
Tipperary
Tipperary
Production Planner
Meath
Meath
Project Engineer
Tipperary
Tipperary
Senior EHS Specialist
Louth
Louth
R&D Director
Galway
Galway
Microbiology Analyst
Dublin
Dublin
Production Operator
Louth
Louth
Facilities Engineer
Carlow
Carlow
Product Development Engineer
Galway
Galway
Consultant
Search Results for Quality Manager
Job Title. | Location | Salary | Actions |
Quality Manager - NPIRole: Quality Manager - NPI Based in Dun Laoghaire – on site role Benefits: Competitive salary, Healthcare, bonus or share options and Pension contribution, excellent opportunity to expand your career in exciting Medical Device company growing from strength to strength. Company: My client have deep expertise and advanced technologies to continuously innovate their pen needles, insulin syringes and other products. Job Purpose: To provide support for ISO9000/ISO13485 Quality System. Responsible for ensuring adherence to al...Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South, |
EU | Not Disclosed | |
Quality Manager - NPIRole: Quality Manager - NPI Based in Dun Laoghaire – on site role Benefits: Competitive salary, Healthcare, bonus or share options and Pension contribution, excellent opportunity to expand your career in exciting Medical Device company growing from strength to strength. Company: My client have deep expertise and advanced technologies to continuously innovate their pen needles, insulin syringes and other products. Job Purpose: To provide support for ISO9000/ISO13485 Quality System. Responsible for ensuring adherence to al...Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South, |
EU | Not Disclosed | |
Quality ManagerJob title: Quality Engineer/ Quality Manager Location: ATU Ihub, Galway Company: My client are a developer of innovative medical devices which transform the mobility and quality of life of enteral feeding users. Their team understands that current feeding systems are complex, inconvenient and a burden on users’ daily lives. My client have developed the Mobility+® the first of its kind FDA cleared Elastomeric enteral feeding system. The Mobility+® is now available in the US market and has FDA Approval. Overview: As a Quality Engi...Location: Clare, Galway, Galway City, Limerick, Limerick City, |
EU | Not Disclosed | |
QA Representative API External ManufacturingQA Representative API External Manufacturing Our client, a global manufacturing pharma organisation, are currently recruiting for a QA Representative to join their Cork based team on a permanent basis. As QA Rep, you will provide support for the quality activities at Contract Manufacturing organizations (CMOs). This role will involve international travel to ensure that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments. Around 20% travel is anticipated. Responsibilities S...Location: Cork, |
Cork | Not Disclosed | |
Quality ManagerRole: Quality Manager - NPI Based in Dun Laoghaire – on site role Benefits: Competitive salary, Healthcare, bonus or share options and Pension contribution Company: My client have leveraged deep expertise and advanced technologies to continuously innovate their pen needles, insulin syringes and other products. They offer an excellent opportunity for anyone looking to grow their career in the Medical Device industry. Job Purpose: To provide support for ISO9000/ISO13485 Quality System. Responsible for ensuring adher...Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, |
EU | Not Disclosed | |
Quality ManagerRole: Quality Manager - NPI Based in Dun Laoghaire – on site role Benefits: Competitive salary, Healthcare, bonus or share options and Pension contribution Company: My client have leveraged deep expertise and advanced technologies to continuously innovate their pen needles, insulin syringes and other products. They offer an excellent opportunity for anyone looking to grow their career in the Medical Device industry. Job Purpose: To provide support for ISO9000/ISO13485 Quality System. Responsible for ensuring adherence to all exte...Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, |
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 | |
Responsible Person (RP)Life Science Recruitment are delighted to partner with our client, an internationally established dynamic consultancy, to source an experienced RP to join their professional team of consultants on a permanent full time basis. This role will recquire the successful candidate to work with a portfolio of designated clients to ensure compliance with the requirements of GDP and other relevant guidelines both EU and HPRA & UK (MHRA) They will also ensure that the conditions of the Wholesale Distribution Authorisation are met and that all medicinal products wholesaled, are rece...Location: Republic of Ireland, |
Republic of Ireland | 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
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
Valid XHTML - CSS