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R&D Manager
Galway
Senior Recruitment Consultant
Republic of Ireland
Medical Device Director
Republic of Ireland
R&D Manager
Galway
Responsible Person (RP)
Republic of Ireland
C&Q Lead
Tipperary
R&D Engineer
Dublin
Chemical Engineer
Tipperary
CQV Lead
Tipperary
Project Engineer
Republic of Ireland
R&D Director
Galway
Process Engineer
Limerick
Project Engineer
Limerick
R&D Director
Galway
R&D Director
Galway
Project Engineer
Limerick
Head of R&D
Galway
Project Engineer
Tipperary
Trainer
Dublin
R&D Manager
Galway
R&D Manager
Galway
Quality Specialist
Tipperary
Recruitment Consultant
Republic of Ireland
Senior R&D Engineer
Galway City
Analytical Chemist
Tipperary
Senior Recruitment Consultant
Republic of Ireland
Senior Quality Engineer-Remote
Republic of Ireland
Project Manager
Limerick
Senior Manufacting Engineer
Republic of Ireland
Consultant
James Cassidy
Life Science

+353 1 5079250
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Search Results for QA RA Engineer
Job Title. Location Salary Actions

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

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

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

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

QA Representative API External Manufacturing

QA 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,
QA Representative API External Manufacturing
Cork 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

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