Quality Assurance Specialist

1 month ago


Cambridgeshire, United Kingdom BioTalent Full time
Job Description

To provide design control and risk management support to combination product/medical device development programmes. This will chiefly involve the generation and review of documentation required for design history files. Other responsibilities will include facilitation and documentation of risk management activities associated with combination products/medical devices. The role is based in Cambridge; however, project teams are global in nature.

Key Responsibilities:

  • Generation, approval and retention of device design control and risk management documentation ensuring that quality and regulatory requirements are satisfied.
  • Support and facilitation of effective risk management activities at external design companies and manufacturing facilities related to assigned projects.
  • Provide input and support to human factors engineering documentation.
  • Support the assessment of external design companies and suppliers for capability of quality systems, facilities and procedures to support device development and supply.
  • Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture.
  • Support the generation of all regulatory submission data and content for assigned device projects.
  • Support internal and external audits of the DCoE Quality System.

Requirements:

  • Degree, HND or equivalent in relevant subject.
  • History of working in accordance with the requirements of ISO 13485, ISO 14971 and 21 CFR 820.
  • Technical Skills & Requirements:
    • Thorough working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820 and the EU Medical Devices Directive.
    • Working knowledge of EN 62366, EN 60601, EN 62304 and EU Medical Devices Regulation.
    • Able to learn and apply established procedures in a reliable and consistent manner.


  • Cambridgeshire and Peterborough, United Kingdom TRIGO Specialist Resourcing Full time

    Quality Assurance SpecialistTRIGO Specialist Resourcing is seeking a Quality Assurance Specialist to join our dynamic team. As a Quality Assurance Specialist, you will be responsible for providing quality services and support for all missions assigned to a manufacturing or warehouse site while ensuring a healthy and safe work environment.Key...


  • Cambridgeshire and Peterborough, United Kingdom TRIGO Specialist Resourcing Full time

    Quality Technician (Ad-hoc Opportunities Available)Are you looking for flexible work opportunities that fit around your commitments? Whether you're a student, semi-retired, or simply seeking part-time work, TRIGO has roles that cater to your availability and needs. We offer various opportunities within our global organisation, from Inspection to expert...


  • Cambridgeshire and Peterborough, United Kingdom TRIGO Specialist Resourcing Full time

    Quality Technician (Ad-Hoc Opportunities Available)Are you looking for flexible work opportunities that fit around your commitments? Whether you're a student, semi-retired, or simply seeking part-time work, TRIGO has roles that cater to your availability and needs. We offer various opportunities within our global organisation, from Inspection to expert...


  • Cambridgeshire and Peterborough, United Kingdom TRIGO Specialist Resourcing Full time

    Quality Technician (Ad-Hoc Opportunities Available)Are you looking for flexible work opportunities that fit around your commitments? Whether you're a student, semi-retired, or simply seeking part-time work, TRIGO has roles that cater to your availability and needs. We offer various opportunities within our global organisation, from Inspection to expert...


  • Cambridgeshire and Peterborough, United Kingdom TRIGO Specialist Resourcing Full time

    Quality Technician (Ad-hoc Opportunities Available)Are you looking for flexible work opportunities that fit around your commitments? Whether you're a student, semi-retired, or simply seeking part-time work, TRIGO has roles that cater to your availability and needs. We offer various opportunities within our global organisation, from Inspection to expert...

  • Test Technician

    2 weeks ago


    Cambridgeshire, United Kingdom Proclinical Staffing Full time

    Job Title: Test Technician - Quality Assurance SpecialistJob Function: Testing and Quality AssuranceJob Type: Temporary - Contract PositionJob Description:Proclinical Staffing is seeking a Test Technician to support our pet care technology projects in ensuring product quality and reliability. This is a temporary contract position with an immediate...


  • Cambridgeshire and Peterborough, United Kingdom Clinical Professionals Limited Full time

    Job Title: Quality Assurance SpecialistJob Summary: We are seeking a Quality Assurance Specialist to join our team at Clinical Professionals Limited. The successful candidate will be responsible for ensuring the quality and compliance of our medical device and combination product development programs.Key Responsibilities:Lead design control and risk...


  • Cambridgeshire and Peterborough, United Kingdom fish4.co - Jobboard Full time

    We are seeking a Quality Assurance Specialist to join our team at fish4.co - Jobboard. The successful candidate will be responsible for managing our Quality Management System (QMS) and conducting internal and external audits. This role will involve working closely with our team to ensure the highest standards of quality are maintained.The key...


  • Cambridgeshire and Peterborough, United Kingdom Hyper Recruitment Solutions Ltd Full time

    We are seeking a Quality Assurance Specialist to join our team at Hyper Recruitment Solutions Ltd. The successful candidate will be responsible for ensuring the highest standards of design control and risk management throughout the product lifecycle.Key ResponsibilitiesLead design control and risk management activities for combination product development...


  • Cambridgeshire and Peterborough, United Kingdom Aldwych Consulting Full time

    Aldwych Consulting is seeking a skilled Quality Assurance Specialist to join their team on a large and complex civil engineering project. The ideal candidate will have experience in quality assurance and control, with a strong understanding of civil engineering principles and practices.The successful candidate will be responsible for:Conducting independent...


  • Cambridgeshire and Peterborough, United Kingdom Aldwych Consulting Full time

    Aldwych Consulting is seeking a skilled Quality Assurance Specialist to join their team on a large and complex civil engineering project. The ideal candidate will have experience in quality assurance and control, with a strong understanding of civil engineering principles and practices.The successful candidate will be responsible for:Conducting independent...


  • Cambridgeshire, United Kingdom The Collective Network Limited Full time

    Job Title: Quality Assurance ManagerJob Summary:The Quality Assurance Manager plays a critical role in ensuring the highest standards of food safety and quality within food manufacturing operations. This position is responsible for overseeing quality assurance processes, leading a team of QAs, and maintaining product quality to meet regulatory and company...


  • Cambridgeshire and Peterborough, United Kingdom https:www.forcesfamiliesjobs.co.uksitemap Full time

    Job Title: Quality Assurance Specialist - Part TimeWe are seeking a highly skilled Quality Assurance Specialist to join our team on a part-time basis. As an Internal Quality Assessor, you will play a crucial role in ensuring the high standards of quality and compliance across our campuses in Cambridge and Huntingdon.Your key responsibilities will...


  • Cambridgeshire and Peterborough, United Kingdom https:www.forcesfamiliesjobs.co.uksitemap Full time

    Internal Quality Assessor - Part-Time OpportunityWe are seeking a skilled and experienced Internal Quality Assessor to join our team on a part-time basis. As an Internal Quality Assessor, you will play a vital role in ensuring the high standards of quality and compliance across our campuses in Cambridge and Huntingdon.Key Responsibilities:Support the...


  • Cambridgeshire and Peterborough, United Kingdom https:www.forcesfamiliesjobs.co.uksitemap Full time

    Internal Quality Assessor - Part-Time OpportunityWe are seeking a skilled and experienced Internal Quality Assessor to join our team on a part-time basis. As an Internal Quality Assessor, you will play a vital role in ensuring the high standards of quality and compliance across our campuses in Cambridge and Huntingdon.Key Responsibilities:Support the...


  • Cambridgeshire, United Kingdom Henderson Brown Recruitment Full time

    Job Title: Quality Assurance ManagerOur client, a leading food business, is seeking a driven and ambitious Quality Assurance Manager to join their business. As they continue to expand and grow their presence in the marketplace, they require a professional to assist in achieving technical and quality goals.Responsibilities:* Assist in achieving technical and...


  • Cambridgeshire and Peterborough, United Kingdom Cambridge Regional College Full time

    Internal Quality Assessor - Part-Time OpportunityWe are seeking a skilled and experienced Internal Quality Assessor to join our team on a part-time basis. As an Internal Quality Assessor, you will play a vital role in ensuring the high standards of quality and compliance across our campuses in Cambridge and Huntingdon.Key Responsibilities:Support the...


  • Cambridgeshire and Peterborough, United Kingdom Cambridge Regional College Full time

    Internal Quality Assessor - Part-Time OpportunityWe are seeking a skilled and experienced Internal Quality Assessor to join our team on a part-time basis. As an Internal Quality Assessor, you will play a vital role in ensuring the high standards of quality and compliance across our campuses in Cambridge and Huntingdon.Key Responsibilities:Support the...


  • Cambridgeshire and Peterborough, United Kingdom supplychainonline.co - Jobboard Full time

    Job Title: Raw Materials Quality Assurance SpecialistSalary: 35,000 - 40,000Location: CambridgeshireOur client is a leading food business who supply to a variety of the major retailers. This position is perfect for someone looking to take that first step into a quality assurance role. Create, approve, and review raw material specifications to maintain...


  • Cambridgeshire and Peterborough, United Kingdom Cambridge Regional College Full time

    Internal Quality Assessor - Part TimeWe are seeking a skilled Internal Quality Assessor to join our team on a part-time basis. As an Internal Quality Assessor, you will play a vital role in ensuring the high standards of quality and compliance across our campuses in Cambridge and Huntingdon.Key Responsibilities:Support the Work Based Learning Manager in...