Senior Quality Assurance Specialist

4 weeks ago


Cardiff, Cardiff, United Kingdom Walker Cole International Full time

Walker Cole International is seeking a Senior Quality Assurance Specialist to lead quality management processes for a Medical Device company in South Wales. As the Advanced Quality Engineer, you will be responsible for process ownership of design quality and risk management sitewide, and will approve change management activities from a risk and validation perspective.

Key responsibilities of the Senior Quality Assurance Specialist include:

  • Mentor and oversee validation plans, protocols, reports, and requirement specifications
  • Work closely with R&D, clinical and operations, and other business functions to ensure quality performance of product and process
  • Support internal and external audit processes
  • Initiate and lead the development of PHAs, pFMEAs, and dFMEAs

A successful Senior Quality Assurance Specialist will demonstrate:

  • A detailed understanding of the Medical Device manufacturing process
  • Proficiency in ISO 13485, Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP)
  • A good understanding of engineering and quality practices and methods
  • Training in Lean Six Sigma project management approach is a distinct advantage.

Senior Quality Assurance Specialist | Quality Management | Risk Management | Medical Device | MD | Good Manufacturing Practice | GMP | Good Distribution Practice | GDP | Lean Six Sigma | ISO 13485 | Problem Solving | PHAs | pFMEAs | dFMEAs | Design Quality | Preliminary Hazard Analysis | Process Failure Mode and Effective Analysis | Design Failure Mode and Effective Analysis



  • Cardiff, Cardiff, United Kingdom fish4.co - Jobboard Full time

    Walker Cole International is seeking a Senior Quality Assurance Specialist to work with a Medical Device company in South Wales. As the Senior Quality Assurance Specialist, you will be responsible for process ownership of design quality and risk management across the site, as well as approving change management activities from a risk and validation...


  • Cardiff, Cardiff, United Kingdom Walker Cole International Full time

    Walker Cole International is seeking a Senior Quality Assurance Specialist to lead quality management processes for a Medical Device company in South Wales. As the Advanced Quality Engineer, you will be responsible for process ownership of design quality and risk management sitewide, approving change management activities from a risk and validation...


  • Cardiff, Cardiff, United Kingdom Walker Cole International Full time

    Job DescriptionWalker Cole International is seeking a Senior Quality Assurance Specialist to lead the development of quality management systems and processes for a Medical Device company based in South Wales.Key responsibilities of the Senior Quality Assurance Specialist include:Mentor and oversee validation plans, protocols, reports, and requirement...


  • Cardiff, Cardiff, United Kingdom IntaPeople Full time

    Job Title: Senior Quality Assurance SpecialistJob Summary: We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at IntaPeople. As a Senior Quality Assurance Specialist, you will play a key role in managing and improving our quality systems.Key Responsibilities:Ensure compliance with regulatory standards, including CAPA,...


  • Cardiff, Cardiff, United Kingdom Workonblockchain Full time

    Role OverviewWe are seeking a skilled Senior Quality Assurance Specialist to join our team at Workonblockchain. As a QA Analyst, you will be responsible for ensuring the quality of our software products by identifying and reporting defects, and collaborating with cross-functional teams to resolve issues.Key ResponsibilitiesDesign and execute test plans to...


  • Cardiff, Cardiff, United Kingdom ATL Technology Full time

    Job DescriptionJob Title: Senior Quality Assurance SpecialistJob Summary:We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at ATL Technology. As a Senior Quality Assurance Specialist, you will be responsible for managing and improving quality systems processes to ensure EU and US regulatory compliance with relevant company...


  • Cardiff, Cardiff, United Kingdom Jumar group Full time

    Job SummaryWe are seeking a Senior Quality Assurance Specialist to join our team at Jumar Group in Cardiff. As a key member of the test delivery team, you will be responsible for ensuring the highest quality of software solutions.Your main duties will include:Developing and executing comprehensive Test Plans, Test Scripts, and Test ReportsSigning off test...


  • Cardiff, Cardiff, United Kingdom Walker Cole International Full time

    Walker Cole International is seeking a Senior Quality Assurance Specialist to lead the development and implementation of quality management systems within a Medical Device company based in South Wales.As Advanced Quality Engineer for Medical Devices, you will be responsible for process ownership of design quality and risk management site-wide, ensuring...


  • Cardiff, Cardiff, United Kingdom Yolk Recruitment Full time

    Quality Assurance Specialist £40,000 Yolk Recruitment is proud to support this recruitment campaign for a skilled Quality Assurance Specialist to join a leading electronics manufacturing company based in South Wales. This is an exciting opportunity to play a key role in ensuring product excellence within a renowned global business. This is what you'll...


  • Cardiff, Cardiff, United Kingdom Yolk Recruitment Ltd Full time

    At Yolk Recruitment Ltd, we are seeking a skilled Quality Assurance Specialist to join our client, a prominent Engineering company based in South Wales. As a Quality Assurance Specialist, you will play a crucial role in ensuring compliance with customer requirements and maintaining the highest standards of quality in production.The ideal candidate will have...


  • Cardiff, Cardiff, United Kingdom IntaPeople Full time

    Quality Assurance SpecialistIntaPeople is seeking a Quality Assurance Specialist to join their team in Cardiff. As a Quality Assurance Specialist, you will play a key role in managing and improving quality systems.Key Responsibilities:Ensure compliance with regulatory standards, including CAPA, complaints, post-market surveillance, NCR, document control,...


  • Cardiff, Cardiff, United Kingdom Yolk Recruitment Ltd Full time

    Quality Assurance SpecialistYolk Recruitment Ltd is seeking a skilled Quality Assurance Specialist to join their team in South Wales. As a Quality Assurance Specialist, you will be responsible for ensuring compliance with customer requirements and monitoring critical to quality features in production.Key Responsibilities:Collaborate with the Head of QA and...


  • Cardiff, Cardiff, United Kingdom Resourcing Partnership Ltd Full time

    Job Title: Quality Assurance SpecialistJob Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at Resourcing Partnership Ltd. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products throughout the entire product lifecycle.Key Responsibilities:Manage the sampling process for new...


  • Cardiff, Cardiff, United Kingdom Future Full time

    About the RoleWe are seeking a Quality Assurance Specialist to join our team at Future. As a Quality Assurance Specialist, you will play a key role in ensuring the quality of our services and products.Key ResponsibilitiesSupport the Quality Assurance Manager in the delivery of business critical objectives.Conduct clear, fair and accurate reviews and submit...


  • Cardiff, Cardiff, United Kingdom Achieve together Full time

    At Achieve together, we're seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you'll play a vital role in ensuring the delivery of high-quality person-centred care services. Your expertise will be instrumental in driving continuous improvement and ensuring compliance with regulatory frameworks.The Role:As a Quality...


  • Cardiff, Cardiff, United Kingdom PeoplePlus Full time

    Quality Assurance Specialist for ChildcareAt PeoplePlus, we are seeking a highly skilled Quality Assurance Specialist for Childcare to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality in our childcare qualifications.Key responsibilities include:Carrying out internal quality...


  • Cardiff, Cardiff, United Kingdom Strongfield Full time

    About Strongfield">We are a forward-thinking defence sector engineering company, dedicated to delivering high-quality products that meet the highest standards of quality and compliance.">Role Overview">We are seeking a highly skilled Senior Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in mechanical...


  • Cardiff, Cardiff, United Kingdom City & Guilds Full time

    External Quality Assurance SpecialistWe are seeking a highly skilled External Quality Assurance Specialist to join our team at City & Guilds. As an EQA, you will play a crucial role in ensuring the quality of our qualifications and assessments.Key Responsibilities:Carry out quality assurance activities in line with City & Guilds and regulatory...


  • Cardiff, Cardiff, United Kingdom WALKER COLE INTERNATIONAL LTD Full time

    Walker Cole International Ltd is seeking a Senior Quality Assurance Manager to play a vital role in enhancing quality performance within their growing Medical Device Company in Southern Wales.Responsible for leading initiatives and projects, the Senior Quality Assurance Manager will establish and maintain design and clinical-focused QMS Standard Operating...


  • Cardiff, Cardiff, United Kingdom TRITECH GROUP Full time

    Aerospace Quality Assurance SpecialistEstablished in 1982, Tritech Group has built a solid reputation as a significant and respected local employer of choice. We are recruiting for a range of positions across our 8 UK facilities to support our rapid growth.The role of the Aerospace Quality Assurance Specialist is to lead and support all customer, regulatory,...