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Search Results for Quality Specialist
Job Title. Location Salary Actions

Quality Manager

Job 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,
Quality Manager 		Galway Not Disclosed

Senior Quality Engineer

Title: Senior Quality Engineer Location: ATU iHub Galway City. Benefits: Top Salary, share options, hybrid working, flexitime and bonus Company: My client a clinical-stage CE Marked and FDA approved medical device manufacturer. Currently seeking an innovative Quality Assurance professional. The successful candidate will be an active member of the QA/RA team building innovative minimally invasive devices designed specifically for sufferers of chronic venous disease. Product: My clients first product is a mechanical endovenous infusion catheter ...

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

Senior Quality Assurance Engineer

Title: Senior Quality Assurance Engineer Location: ATU iHub Galway City. Benefits: Top Salary, share options, hybrid working, flexitime and bonus Company: My client a clinical-stage CE Marked and FDA approved medical device manufacturer. Currently seeking an innovative Quality Assurance professional. The successful candidate will be an active member of the QA/RA team building innovative minimally invasive devices designed specifically for sufferers of chronic venous disease. Product: My clients first product is a mechanical endovenous infusion...

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

Quality Manager

Job 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,
Quality Manager 		Galway Not Disclosed

Quality Manager

Job 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,
Quality Manager 		Galway Not Disclosed

Senior Audit & Compliance Specialist

Senior Audit & Compliance Specialist This senior position sits within a global healthcare leader’s high-growth Diagnostics business unit. Reporting to the Audit & Inspection Readiness Manager, the successful candidate will lead the supplier audit lifecycle and maintain a state of continuous inspection readiness across multi-site manufacturing networks. Key Responsibilities Audit Lifecycle Leadership: Independently plan, execute, and report on global supplier, internal, and external quality system audits. Compliance: Ensure all Quality...

Location: Galway,
Senior Audit & Compliance Specialist 		Galway Not Disclosed

Quality Manager

Title: QA / RA Manager Location: ATU Ihub, Dublin Road, Galway Company: My client are a Medical are an early-stage start-up focused on developing patient solutions in the area of palliative care. Their initial technology platform is a catheter-based device used to treat the build-up of fluid in the body. Role: QARA Manager with DA focus on a 9-month contract basis who will thrive in a multidisciplinary start-up environment. Looking for people that are curious, have a similar strong work ethic to our own, and are motivated by the positive influe...

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

Quality Manager

Title: QA / RA Manager Location: ATU Ihub, Dublin Road, Galway Company: My client are a Medical are an early-stage start-up focused on developing patient solutions in the area of palliative care. Their initial technology platform is a catheter-based device used to treat the build-up of fluid in the body. Role: QARA Manager with DA focus on a 9-month contract basis who will thrive in a multidisciplinary start-up environment. Looking for people that are curious, have a similar strong work ethic to our own, and are motivated by the positive influe...

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

Quality Manager

Title: QA / RA Manager Location: ATU Ihub, Dublin Road, Galway Company: My client are a Medical are an early-stage start-up focused on developing patient solutions in the area of palliative care. Their initial technology platform is a catheter-based device used to treat the build-up of fluid in the body. Role: QARA Manager with DA focus on a 9-month contract basis who will thrive in a multidisciplinary start-up environment. Looking for people that are curious, have a similar strong work ethic to our own, and are motivated by the positive influe...

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

Principal Design Assurance Engineer

Job title: Principal Design Assurance Engineer Location: Parkmore Business Park, Galway. Benefits: Excellent salary, bonus, pension, healthcare, opportunity to grow your career with hugely exciting Medical Device organisation. Company: My client are an early stage Irish MedTech company located in Galway, a global centre for excellence in medical technologies. The company collaborates with clinicians and research institutions across the world developing and commercialising a new technology platform for endovascular surgery that wi...

Location: Galway, Galway City,
Principal Design Assurance Engineer 		Galway Not Disclosed

Quality Engineer

Title: Quality Engineer Location: Galway business park, Galway Benefits: Salary, share options, pension, hybrid working and healthcare Company: My client are a Medical Device company in a growth stage. 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. Culture: An inclusive work environment, where all the employees are valued, supported, and ...

Location: Galway, Galway City,
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

Quality Engineer - Supplier

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,
Quality Engineer - Supplier 		Galway Not Disclosed

Quality Engineer - Supplier

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,
Quality Engineer - Supplier 		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

Quality Engineer - Supplier

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,
Quality Engineer - Supplier 		Galway Not Disclosed

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

Quality Assurance Specialist/Manager

Quality Assurance Specialist/Manager Our client, a pharmaceutical organisation, are currently recruiting for a Quality Specialist/Manager to join their team on a permanent basis. As Quality Assurance Specialist/Manager you will play a key role in ensuring compliance with Good Distribution Practice (GDP) requirements and supporting quality activities across the organisation and its affiliates. You will work closely with cross-functional teams including Regulatory Affairs, Pharmacovigilance, Medical Affairs, and Supply Chain, as well as with external partners and regu...

Location: Dublin,
Quality Assurance Specialist/Manager 		Dublin Not Disclosed

Senior Quality Systems Engineer

Role: Senior Quality Systems Engineer Location: ATU Ihub - Galway Benefits: Top salary, hybrid working, bonus, pension and Shares Company: Brand new Medical Device start up with exciting new adventure. Role: Senior Quality Systems Engineer you will play a key role in the Set up, implementation and maintenance of the company’s Quality Management System.This is a fantastic opportunity, which will allow you to work as part of a supportive, collaborative team in...

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

Senior Quality Systems Engineer

Role: Senior Quality Systems Engineer Location: Parkmore, Galway (Hybrid working) Benefits: Top salary, hybrid working, bonus, pension and healthcare 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 Quality Systems Manager, as a Senior Quality Systems Engineer you will play a key role in the implementation and maintenance o...

Location: Galway, Galway City,
Senior Quality Systems 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

Design Assurance Engineer

Role: Design Assurance Engineer Location: Oranmore, Galway (Hybrid working) Benefits: Excellent salary, pension, healthcare, yearly bonus and share options. 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 a Design Assurance Engineer to work play a key role in supporting the lifecycle of our commercially released medical device products. The role involves managing design changes, ensuring continued compliance with risk managemen...

Location: Galway, Galway City,
Design Assurance 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 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 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

Senior Associate Quality Control

Senior Associate Quality Control AS3646 12 Months Dublin We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties: • Plan and perform analyses with great efficiency and accuracy. • Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays. • Report, evaluate, back-up/archive, t...

Location: Dublin,
Senior Associate Quality Control 		Dublin Not Disclosed

Quality Assurance Engineer

JOB TITLE: Quality Assurance Engineer LOCATION: Castlerea, Roscommon (On site) BENEFITS: Good salary, 5% bonus, Healthcare and pension SUMMARY: Reporting to the Quality Engineering Manager, the Quality Assurance Engineer will provide ongoing Quality support in an effort to maximise production quality performance, including identifying root cause, implementing corrective/preventive action on all quality issues in production. Scope of role will also include addressing any customer and internal related issues identified in the manufacturing ...

Location: Longford, Midlands, Roscommon, Sligo, Westmeath,
Quality Assurance 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 Quality Engineer

Role: Senior Quality Engineer 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 Integration & Maintenance of the Quality Management System with all Freudenberg Medi...

Location: Leitrim, Longford, Midlands, Roscommon, Sligo,
Senior Quality Engineer 		EU Not Disclosed

Senior Quality Engineer

Role: Senior Quality Engineer 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 Integration & Maintenance of the Quality Management System with all Freudenberg Medi...

Location: Leitrim, Longford, Midlands, Roscommon, Sligo,
Senior Quality Engineer 		EU Not Disclosed

Senior Quality Engineer

Role: Senior Quality Engineer 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 Integration & Maintenance of the Quality Management System with all Freudenberg Medi...

Location: Leitrim, Longford, Midlands, Roscommon, Sligo,
Senior Quality Engineer 		EU Not Disclosed

Senior Quality Engineer

Role: Senior Quality Engineer 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 Integration & Maintenance of the Quality Management System with all Freudenberg Medica...

Location: Leitrim, Longford, Roscommon,
Senior Quality Engineer 		Leitrim 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 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

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

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 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
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Quality Specialist Career Profile

Quality Specialist


The Quality Specialist is responsible for the review, approval and processing of document change requests, assisting in the development and maintenance of the quality management system, acting as Lead Auditor, developing quality KPIs and supporting the complaint handling process. Typically the QA Specialist will have a degree in Life Science or Pharmacy and have 2-3 years experience in the area of quality assurance and will ideally have experience within the quality departments of a Medical Device company or a regulatory agency.
Key responsibilities of the Quality Assurance Specialist

  • Ensuring that area procedures are correct and updated as necessary.
  • Review of document change requests to evaluate each change for quality related issues.
  • LMS administrator for QA function.
  • Assist in the development and maintenance of the quality system as required, ensuring compliance to ISO13485:2003.
  • Provide guidance to Technical Service and Customer Service on quality system issues.
  • Contribute to making the operation efficient and compliant by effective liaison with all departments in quality matters.
  • Facilitate internal audits of the systems and processes on a regular basis as performed by the internal audit team. Act as Lead Auditor.
  • Participate and report at management review and assist in resolving issues that may arise.
  • Conduct QMS training for all employees.
  • Participate in the development of the department KPIs. Assist in the preparation of internal statistical reports (KPIs).
  • Schedule, chair and report at routine quality focused meetings influencing change and developing best practices.
  • Function as QA support in handling Corrective and Preventive Action requests in the internal CAPA system.
  • Liaise with external groups in relation to complaint handling systems i.e. complaint investigation centres and complaint management centres.