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Project Manager
Limerick
Project Engineer
Tipperary
Recruitment Consultant
Republic of Ireland
Medical Device Director
Republic of Ireland
R&D Manager
Galway
R&D Director
Galway
Senior Recruitment Consultant
Republic of Ireland
Chemical Engineer
Tipperary
R&D Engineer
Dublin
Project Engineer
Limerick
Quality Specialist
Tipperary
C&Q Lead
Tipperary
Analytical Chemist
Tipperary
Senior R&D Engineer
Galway City
R&D Manager
Galway
Responsible Person (RP)
Republic of Ireland
Senior Quality Engineer-Remote
Republic of Ireland
R&D Manager
Galway
Trainer
Dublin
R&D Director
Galway
CQV Lead
Tipperary
Senior Recruitment Consultant
Republic of Ireland
Senior Manufacting Engineer
Republic of Ireland
Project Engineer
Limerick
R&D Manager
Galway
Project Engineer
Republic of Ireland
Operations Lead
Dublin South
Head of R&D
Galway
Process Engineer
Limerick
R&D Director
Galway
Search Results for Quality Systems Engineer
Job Title. Location Salary Actions

Quality Assurance Specialist

Job title: Quality Assurance Specialist Location: Western Business Park, Shannon, Co. Clare Benefits: Good salary, Healthcare, pension, opportunity to grow your career with exciting Medical Device company working on projects from concept. Summary: The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System with my Medical Device client in order to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements. The QMS includes medical device design...

Location: Clare, Limerick, Limerick City, Republic of Ireland,
Quality Assurance Specialist
EU Not Disclosed

Senior Quality Engineer

Job title: Senior Quality Assurance Engineer Location: Oranmore, Galway Benefits: Excellent salary, Income Protection, Life Assurance, Contribution of €2,000 per annum in lieu of health insurance, Pension Scheme, Annual discretionary bonus up to 10%, Educational Assistance, Employee Referral Programme, Cycle to Work Scheme, Sports & Social Activities Role: As a Senior Quality Engineer you will be responsible for implementing and promoting best in class quality assurance through the product lifecycle for my client device. C...

Location: Galway, Galway City,
Senior Quality Engineer
Galway Not Disclosed

Quality Engineer

Job title: Quality Engineer Location: Oranmore, Galway Benefits: Excellent salary, Income Protection, Life Assurance, Contribution of €2,000 per annum in lieu of health insurance, Pension Scheme, Annual discretionary bonus up to 10%, Educational Assistance, Employee Referral Programme, Cycle to Work Scheme, Sports & Social Activities Role: As a Quality Engineer you will join the Operations team. And play a pivotal role in ensuring the quality and compliance of our manufacturing processes, contributing to the delivery of me...

Location: Galway, Galway City,
Quality Engineer
Galway Not Disclosed

Quality Engineer

Job title: Quality Engineer Location: Oranmore, Galway Benefits: Excellent salary, Income Protection, Life Assurance, Contribution of €2,000 per annum in lieu of health insurance, Pension Scheme, Annual discretionary bonus up to 10%, Educational Assistance, Employee Referral Programme, Cycle to Work Scheme, Sports & Social Activities Role: As a Quality Engineer you will join the Operations team. And play a pivotal role in ensuring the quality and compliance of our manufacturing processes, contributing to the delivery of me...

Location: Galway, Galway City,
Quality Engineer
Galway Not Disclosed

Senior Quality Engineer

Job title: Senior Quality Assurance Engineer Location: Oranmore, Galway Benefits: Excellent salary, Income Protection, Life Assurance, Contribution of €2,000 per annum in lieu of health insurance, Pension Scheme, Annual discretionary bonus up to 10%, Educational Assistance, Employee Referral Programme, Cycle to Work Scheme, Sports & Social Activities Role: As a Senior Quality Engineer you will be responsible for implementing and promoting best in class quality assurance through the product lifecycle for my client device. C...

Location: Galway, Galway City,
Senior Quality Engineer
Galway Not Disclosed

Senior Quality Engineer

Job title: Senior Quality Assurance Engineer Location: Oranmore, Galway Benefits: Excellent salary, Income Protection, Life Assurance, Contribution of €2,000 per annum in lieu of health insurance, Pension Scheme, Annual discretionary bonus up to 10%, Educational Assistance, Employee Referral Programme, Cycle to Work Scheme, Sports & Social Activities Role: As a Senior Quality Engineer you will be responsible for implementing and promoting best in class quality assurance through the product lifecycle for my client device. ...

Location: Galway, Galway City,
Senior Quality Engineer
Galway Not Disclosed

Quality Systems Enginer

Role: Quality Systems Engineer 24 month ftc with strong chance of going permanent. Based in Dun Laoghaire – on site role Competitive salary, Healthcare, bonus or share options. Pension contribution from company after 24 months. Job Purpose: Reporting to the Quality Systems Manager, duties will include implementing & maintaining the Company’s Quality Management System in accordance with applicable standards and regulations Responsibilities: Be a key driver of cGMP practices within Operations and Quality divisions Act as a p...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Quality Systems Enginer
EU Not Disclosed

Quality Manager - NPI

Role: 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,
Quality Manager - NPI
EU Not Disclosed

Senior Quality Engineer

Title: 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...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Senior Quality Engineer
EU Not Disclosed

Quality Manager - NPI

Role: 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,
Quality Manager - NPI
EU Not Disclosed

Quality Manager

Job 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,
Quality Manager
EU Not Disclosed

Quality Manager

Role: 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,
Quality Manager
EU Not Disclosed

Quality Manager

Role: 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,
Quality Manager
EU Not Disclosed

Senior Quality Engineer

Title: 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,
Senior Quality Engineer
EU Not Disclosed

Quality Engineer

Role: Quality Engineer Location: Mullingar, Westmeath (On site) Benefits: Good salary, pension, healthcare and yearly bonus. Company: My client are an exciting business located in a modern state of the art facility in Mullingar Co. Westmeath. Passionate about serving the world’s medical device and allied healthcare industries in offering a range of the highest quality innovative healthcare packaging solutions. Role: Reporting to the Senior Quality engineer and/or Quality and Regulatory Director the Quality Engineer will work in collaboration with the s...

Location: Athlone, Cavan, Dublin, Kildare, Longford,
Quality Engineer
EU Not Disclosed

Quality Systems Manager

Company: 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,
Quality Systems Manager
EU Not Disclosed

Senior Quality Engineer

Title: 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,
Senior Quality Engineer
EU Not Disclosed

Quality Engineer

Role: Quality Engineer Location: Mullingar, Westmeath (On site) Benefits: Good salary, pension, healthcare and yearly bonus. Company: My client are an exciting business located in a modern state of the art facility in Mullingar Co. Westmeath. Passionate about serving the world’s medical device and allied healthcare industries in offering a range of the highest quality innovative healthcare packaging solutions. Role: Reporting to the Senior Quality engineer and/or Quality and Regulatory Director the Quality Engineer will work in collaboration with the s...

Location: Athlone, Cavan, Dublin, Kildare, Longford,
Quality Engineer
EU Not Disclosed

Design Assurance Supervisor

Role: Design Assurance Supervisor Location: Ballina(Hybrid working) Department: Continence Care Salary and benefits: Good salary, yearly bonus, pension and full family healthcare. Company : My client are one of the worlds leading Medical Device companies who manufacture a high volume of products for global distribution that support their ostomy care and continence care product lines using leading edge automated technologies. Summary: The Design Quality Assurance team is an integral part of developing and bringing to ...

Location: Mayo,
Design Assurance Supervisor
Mayo Not Disclosed

Quality Systems Engineer Career Profile

Quality Systems Engineer


A Quality System is responsible for the design, implantation and maintenance of Quality Systems in a medical device company.

Role/Responsibilities

  • Quality System compliance to ISO9001, ISO13485 and Medical Devices Directive
  • Represent EMEA on global quality initiatives
  • Liaise with EMEA manufacturing sites and subcontractors
  • Drive and implement Quality System Improvements Perform audits of subcontractors
  • Perform internal audits
  • Support external audits
  • Manage CAPA and Event Investigations for site

Skills/Experience

  • Engineer/Science qualification with minimum of 8 years working within QA/RA in a multi-national Medical Devices environment
  • Attention to detail and accuracy - essential
  • Ability to work well under deadlines and pressure
  • Problem solving skills for developing creative solutions and meeting objectives are required
  • Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel)
  • Excellent analytical ability
  • Communication skills
  • The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.