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Search Results for QA RA Engineer
Job Title. Location Salary Actions

Supplier Quality Engineer

Title: Supplier Quality Engineer Location: Galway business park, Galway Benefits: Salary, share options, pension, hybrid working and healthcare Company: My client are a growth stage medical device company, dedicated to improving the quality of life for stroke patients. Developing innovative catheter-based technology to extract blood clots from the brain following an Acute Ischemic Stroke, recently received FAD approval. Overview: A Supplier Quality Engineer (SQE) is responsible for managing the quality aspects of materials and services provided ...

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

Senior Quality Engineer

Job 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,
Senior Quality Engineer 		EU Not Disclosed

Regulatory Specialist

Title: Regulatory Specialist Location: Galway business park, Galway Benefits: Salary, bonus, pension, hybrid working and healthcare Overview: As a Regulatory Specialist you will support the commercialisation of Medical Device products. This includes preparation and submission of regulatory filings for product market entry, as well as regulatory activities required for the maintenance of existing commercial products. The position requires a high level of innovative thought and problem-solving skills. In order to coordinate the variety of regulatory related task...

Location: Galway, Galway City,
Regulatory Specialist 		Galway Not Disclosed

Design Quality Engineer

Role: Design Assurance Engineer Location: Oranmore, Galway Benefits: Excellent salary, pension, healthcare and yearly bonus Company: My client is a Medical Device company developing highly innovative non-surgical interventions that treat chronic inflammatory Sino-Nasal diseases. They are looking for 2 Design Assurance Engineers to work on a Product development stage Next Gen device - currently in concept phase plan to move into design & development Feb/March 2023. Also an Existing device – commercially released but iterative chan...

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

Reg Affairs Specialist

Role: Regulatory Affairs Engineer Location: Parkmore, Galway (Hybrid working) Benefits: Top salary Company: My client are a growing Medical Device company who have recently moved into a high tech new site in Parkmore. They have developed an innovative new technology to improve the performance of Vascular stents. Role: Reporting to the Senior Regulatory Affairs Manager, as a Regulatory Affairs Specialist you will play a key a key role in the implementation of post-market activities within Veryan. This is a ...

Location: Connaught, Galway, Galway City, Leitrim, Limerick,
Reg Affairs Specialist 		EU Not Disclosed

Quality Engineer

Job title : Quality Engineer Location: Galway Business Park, Dangan Benefits: Competitive salary, 10% bonus, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages. Company: My client an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease. This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention. ...

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

Quality Engineer

Job title : Quality Engineer Location: Galway Business Park, Dangan Benefits: Competitive salary, 10% bonus, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages. Company: My client an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease. This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention. ...

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

Senior Design Assurance Engineer

Job title: Senior Design Assurance Engineer Location: Parkmore Business Park, Galway (Hybrid working 2 days a week on site) Benefits: Competitive salary, 10% bonus, Hybrid working, Full family healthcare, flexible working hours and pension contribution. Also an excellent opportunity to build your career with an exciting Medical Device company going through a growth phase. Company: My client are a rapidly growing medical device company offering a highly differentiated solution in SFA interventions. Their culture of innovation helps each indi...

Location: Athlone, Clare, Connaught, Galway, Galway City,
Senior Design Assurance Engineer 		EU Not Disclosed

Quality Engineer

Job title : Quality Engineer Location: Galway Business Park, Dangan Benefits: Competitive salary, 10% bonus, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages. Company: My client an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease. This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention. ...

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

Quality Engineer

Job title : Quality Engineer Location: Galway Business Park, Dangan Benefits: Competitive salary, 10% bonus, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages. Company: My client an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease. This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention. ...

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

Quality Engineer

Job title : Quality Engineer Location: Galway Business Park, Dangan Benefits: Competitive salary, 10% bonus, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages. Company: My client an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease. This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention. ...

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

Quality Engineer

Job title : Quality Engineer Location: Galway Business Park, Dangan Benefits: Competitive salary, 10% bonus, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages. Company: My client an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease. This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention. ...

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

Quality Engineer

Job title : Quality Engineer Location: Galway Business Park, Dangan Benefits: Competitive salary, 10% bonus, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages. Company: My client an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease. This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention. ...

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

Quality Specialist

Job title: Quality Assurance Specialist Location: Western Business Park, Shannon, Co. Clare Benefits: Good salary, Healthcare, pension, 25 days holidays, 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 m...

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

Quality Engineer

Job title : Quality Engineer II Location: Galway Business Park, Dangan Benefits: Competitive salary, 10% bonus, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages. Company: My client an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease. This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention. Overview...

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

Quality Specialist

Job title: Quality Assurance Specialist Location: Western Business Park, Shannon, Co. Clare Benefits: Good salary, Healthcare, pension, 25 days holidays, 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 m...

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

Quality Engineer

Job title : Quality Engineer Location: Galway Business Park, Dangan Benefits: Competitive salary, 10% bonus, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages. Company: My client an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease. This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention. ...

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

Quality Engineer

Job title : Quality Engineer Location: Galway Business Park, Dangan Benefits: Competitive salary, 10% bonus, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages. Company: My client an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease. This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention. ...

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

Quality Specialist

Job title: Quality Assurance Specialist Location: Western Business Park, Shannon, Co. Clare Benefits: Good salary, Healthcare, pension, 25 days holidays, 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 m...

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

Validation Engineer

Role: Validation Engineer Location: Carrick on Shannon, Leitrim Benefits: Competitive salary, Bonus, pension, healthcare and hybrid working Company: Work with theLargest employer in Leitrim show specialise in making Catheters all inhouse. Work in a company have cleanrooms dedicated to customers, very specialised. Generally have about 100 promotions per year – Projects involved, individual plans, goal setting, leadership training. Responsibilities Ensuring that product introductions & change controls ar...

Location: Athlone, Cavan, Connaught, Donegal, Leitrim,
Validation Engineer 		EU Not Disclosed

Quality Engineer

Role: Quality Engineer Location: Carrick on Shannon, Leitrim Benefits: Competitive salary, Bonus, pension, healthcare and hybrid working Company: Work with theLargest employer in Leitrim show specialise in making Catheters all inhouse. Work in a company have cleanrooms dedicated to customers, very specialised. Generally have about 100 promotions per year – Projects involved, individual plans, goal setting, leadership training. Responsibilities Assist with the implementation and development of the site QMS in line with the ...

Location: Athlone, Connaught, Leitrim, Longford, Midlands,
Quality Engineer 		EU Not Disclosed

Senior Regulatory Affairs Specialist

Job title: Senior Regulatory Affairs Specialist Location: Parkmore, Galway. 1 day a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Reporting to the Se...

Location: Athlone, Clare, Connaught, Galway, Galway City,
Senior Regulatory Affairs Specialist 		EU Not Disclosed

Senior Regulatory Affairs Specialist

Job title: Senior Regulatory Affairs Specialist Location: Parkmore, Galway. 1 day a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Reporting to the Se...

Location: Athlone, Clare, Connaught, Galway, Galway City,
Senior Regulatory Affairs Specialist 		EU Not Disclosed

Senior Regulatory Affairs Specialist

Job title: Senior Regulatory Affairs Specialist Location: Parkmore, Galway. 1 day a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Reporting to the Se...

Location: Athlone, Clare, Connaught, Galway, Galway City,
Senior Regulatory Affairs Specialist 		EU Not Disclosed

QA Engineer

Role: QA Engineer (Validation) Location: Carrick on Shannon, Leitrim Benefits: Competitive salary, Bonus, pension and healthcare Company: Work with theLargest employer in Leitrim show specialise in making Catheters all inhouse. Work in a company have cleanrooms dedicated to customers, very specialised. Generally have about 100 promotions per year – Projects involved, individual plans, goal setting, leadership training. Responsibilities Ensuring that product introductions & change controls are effectively managed...

Location: Leitrim, Longford, Midlands, Roscommon,
QA Engineer 		EU Not Disclosed

Quality Technician

Title: Quality Technician Location : The Digital Hub, Rainsford St, Dublin 8. Benefits: Competitive salary, Health insurance and Hybrid working Company: My client are a Medical Device company who started up in 2010 and have developed and patented a bimodal neuromodulation technology that it is evaluating for neurological disorders. The lead application of this technology is through a device which has been shown to soothe and relieve tinnitus, a condition affecting 10% of the adult ...

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

Quality Technician

Title: Quality Technician Location : The Digital Hub, Rainsford St, Dublin 8. Benefits: Competitive salary, Health insurance and Hybrid working Company: My client are a Medical Device company who started up in 2010 and have developed and patented a bimodal neuromodulation technology that it is evaluating for neurological disorders. The lead application of this technology is through a device which has been shown to soothe and relieve tinnitus, a condition affecting 10% of the adult population and commonly known as 'ringing in the ears'. Having launched in...

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

Senior Regulatory Affairs Specialist

Job title: Senior Regulatory Affairs Specialist – Premarket Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Company: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. This role is best suited to an individual who is self-motivated, accountable and seeking infinite learning and growth opportunities. Role: As a Senior Regulatory Affairs Specialist you will will pl...

Location: Clare, Connaught, Galway, Galway City, Limerick,
Senior Regulatory Affairs 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

Senior Quality Engineer

Senior Quality Engineer: Our client a high potential medical device start up are currently seeking a Senior Quality Engineer to join their team. The role is stand alone and has the potential for this position to develop into a Quality Manager Role. The Senior Quality Engineer will provide experienced ongoing Quality support to internal design and development team in addition to managing and advising suppliers on quality performance. The primary objective of the Senior Quality Engineer role is to ensure the requirements of the Quality M...

Location: Dublin,
Senior Quality Engineer 		Dublin 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

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 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

Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist Our client a high potential medical device start up current seeks a Senior Regulatroy Affairs Specialist to join their team. Reporting to the Director of Quality and Regulatory Affairs the Senior Regulatory Affairs will take an active role in developing the Regulatory strategy in Europe and the US and interacting with the relevant Regulatory and Notified Bodies. They will also be required to help maintain the Design History Fileof Class III implant. This position offers the opportunity to join in an exciting early stage company developing a...

Location: Dublin,
Senior Regulatory Affairs Specialist 		Dublin Not Disclosed
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QA RA Engineer Career Profile


QA / RA Specialist

A role combining Quality Assurance and Regulatory Affairs, more often found in the Medical Device sector
Main Responsibilities
  • Apply technical solutions to problem solving
  • Apply technical solutions to quality improvement projects
  • Use technical writing skills to clearly describe technical information
    • Analyze customer complaints, identify trends and execute corrective actions
  • Understand standards and their application to medical devices
  • Planning, protocol generation, testing and report generation for medical devices
  • Generation and maintenance of technical files for medical devices
  • Review and update technical files in line with EU medical devices regulatory requirements
  • The use of harmonised standards when compiling a technical file in compliance with the MDD
  • Ensuring that records are filed in accordance with site procedures
  • Supporting R&D

Skills / Experience
  • Engineering / Science qualification
  • 3/4 years experience within R&D / QA/ RA/ Compliance or Validation function in a Medical Device Environment
  • Excellent technical writing experience within a medical device environment
  • 2/3 years experience in Risk, Clinical and Biocompatibility an advantage
  • Fluency in English