Senior Quality Assurance Specialist

1 month ago


Cambridge, Cambridgeshire, United Kingdom CK GROUP Full time
Job Title: Senior Quality Assurance Specialist

CK Group is seeking a Senior Quality Assurance Specialist to join their team in Cambridge. This is a contract position for 12 months.

Key Responsibilities:

  • Lead design control and risk management activities for combination product development programs.
  • Support and facilitate effective risk management activities at external design companies and manufacturing facilities related to assigned projects.
  • Ensure combination product development activities are compliant with quality and regulatory standards.
  • Provide input and support to design validation including, but not limited to, human factors engineering assessments.

Requirements:

  • BSc in an appropriate science and engineering discipline with previous experience in pharmaceutical combination product and/or device industries.
  • History of working in accordance with the requirements of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
  • Experience in design controls and risk management for combination products.
  • Familiar with Human Factors Engineering - Usability Engineering.
  • Familiar with device assembling manufacturing processes.

About the Company:

Our client is a world-leading biopharmaceutical company, discovering, developing, and providing over 160 different medicines, vaccines, and consumer healthcare products to improve the lives of millions of people in the UK and around the world.

Location:

This role is based at our client's site in Cambridge, with hybrid working arrangements offering 2-3 days per week on-site.

Apply:

Applicants must hold entitlement to work in the UK. Please quote job reference 106705 in all correspondence.

Notes:

This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.



  • Cambridge, Cambridgeshire, United Kingdom Allegis Group Full time

    Job SummaryA leading blue chip company in the UK is seeking a skilled Senior Video Quality Assurance Specialist to join their team in Cambridge.This role involves utilizing custom software applications and test scripts for video quality assessment and network bandwidth testing. The ideal candidate will possess a strong understanding of video processing tools...


  • Cambridge, Cambridgeshire, United Kingdom Adecco UK LTD Full time

    About us: We are a leading software development company that pushes the boundaries of technology and excels in the field of artificial intelligence. We are looking for a Senior Quality Assurance Specialist to join our innovative and boundary-pushing team.Job Description:We are seeking a Quality Assurance Engineer with a passion for innovation to join our...


  • Cambridge, Cambridgeshire, United Kingdom Ernest Gordon Recruitment Careers Full time

    About the Role:Ernest Gordon Recruitment Careers is seeking an experienced Senior Engineering Quality Assurance Specialist to join our team. As an Internal Quality Assurer, you will conduct quality assurance activities, ensuring adherence to teaching, learning, and assessment standards.Key Responsibilities:Manage assessment documentation and provide timely...


  • Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time

    Job Title: Quality Assurance SpecialistAbout the Role:We are seeking a highly skilled Quality Assurance Specialist to join our team at Newton Colmore Consulting Ltd. As a Quality Assurance Specialist, you will be responsible for assisting in the development of the QMS system for ISO 13485 standards.Key Responsibilities:Creating and managing technical files...


  • Cambridge, Cambridgeshire, United Kingdom Blackfield Associates Full time

    Blackfield Associates is partnering with an innovative biotechnology company based in the UK to find a Quality Assurance Specialist.The Quality Assurance Specialist will play a vital role in operating the Quality Management System in compliance with current Good Manufacturing Practices.Key responsibilities include implementing and managing a cGMP-compliant...


  • Cambridge, Cambridgeshire, United Kingdom Skanska Full time

    Job Title: Quality Assurance SpecialistAs a Quality Assurance Specialist, you will be responsible for ensuring the quality of our software products. This involves testing and evaluating our software to identify areas for improvement.Key Responsibilities:Develop and execute test plans to ensure software meets quality standardsIdentify and report defects to...


  • Cambridge, Cambridgeshire, United Kingdom Rubicon People Partnership Full time

    Quality Assurance SpecialistAt Rubicon People Partnership, we're seeking a meticulous Quality Assurance Specialist to join our team. As a key member of our manufacturing process, you'll be responsible for ensuring the accuracy and safety of mechanical components.Key Responsibilities:Conduct methodical inspections to identify defects and ensure quality...


  • Cambridge, Cambridgeshire, United Kingdom Ernest Gordon Recruitment Limited Full time

    Quality Assurance SpecialistErnest Gordon Recruitment Limited is seeking a Quality Assurance Specialist to join their team. As a Quality Assurance Specialist, you will be responsible for conducting quality assurance activities to uphold teaching and assessment standards. This includes managing assessment documentation, providing timely feedback to...


  • Cambridge, Cambridgeshire, United Kingdom CHR Life Sciences Full time

    Quality Assurance SpecialistThe Quality Assurance Specialist at CHR Life Sciences is responsible for providing support for all quality matters, including the implementation of quality procedures and ensuring corrective actions are taken to minimize future occurrences.This role involves maintaining and managing the electronic Quality Management System (eQMS)...


  • Cambridge, Cambridgeshire, United Kingdom Marshall Full time

    Quality Assurance SpecialistWe are seeking a Quality Assurance Specialist to join our team at Marshall. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services.Responsibilities:Write, implement and maintain Project Quality plans.Conduct Project audits to demonstrate compliance to the specific project...


  • Cambridge, Cambridgeshire, United Kingdom Intertek Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Intertek Melbourn.The successful candidate will be responsible for designing, agreeing, and producing proforma templates in conjunction with laboratory staff to promote accuracy and consistency of data recording for assigned analytical methods.Key responsibilities...


  • Cambridge, Cambridgeshire, United Kingdom taylorollinson Ltd Full time

    Our client, a pioneering biotechnology company based in Cambridge, is seeking a Quality Assurance Specialist to support the development and maintenance of their Quality Management System (QMS) within a Good Manufacturing Practice (GMP) compliant environment.The ideal candidate will have prior experience in GMP quality assurance and QMS experience within a...


  • Cambridge, Cambridgeshire, United Kingdom ENGINEERINGUK Full time

    Job DescriptionAt ENGINEERINGUK in Cambridge, we are seeking a skilled Quality Assurance Specialist to join our embedded software development team. As a key member of the team, you will play a crucial role in developing and delivering high-quality products.We are looking for someone who is passionate about building IoT products and has a strong sense of...


  • Cambridge, Cambridgeshire, United Kingdom Proclinical Staffing Full time

    Job Title: Test Technician (Lab)Job Function: Quality Assurance and TestingThis role involves supporting our pet care technology projects with a focus on ensuring product quality and reliability. This is a temporary position with an immediate start.Key Responsibilities:- Conduct testing on pet care technology products.- Maintain testing equipment and ensure...


  • Cambridge, Cambridgeshire, United Kingdom Marshall Full time

    About the Role:We are seeking a Quality Assurance Specialist to join our team at Marshall. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services.Key Responsibilities:Write, implement and maintain Project Quality plans.Conduct Project audits to demonstrate compliance to the specific project defined...


  • Cambridge, Cambridgeshire, United Kingdom Marshall Full time

    Job SummaryMarshall is seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services.Key ResponsibilitiesWrite, implement, and maintain project quality plans.Conduct project audits to demonstrate compliance to specific project-defined plans and...


  • Cambridge, Cambridgeshire, United Kingdom Marshall Group Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Marshall Group. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services, and for identifying and implementing improvements to our quality control processes.Key ResponsibilitiesPerform quality control checks on...


  • Cambridge, Cambridgeshire, United Kingdom Marshall Full time

    About the Role:We are seeking a Quality Assurance Specialist to join our team at Marshall. As a Quality Assurance Specialist, you will be responsible for performing standardized quality control checks on our company products to ensure they meet the required legal and company standards for safety and quality.Key Responsibilities:Developing and maintaining...


  • Cambridge, Cambridgeshire, United Kingdom Teaching Personnel Full time

    Job DescriptionRole: Education Specialist - Quality Assurance and ImprovementContract: PermanentArea: Cambridge, UKSalary: £32,280 per annum (estimated based on national averages for the education sector in the UK)About the RoleWe are seeking an experienced Education Specialist to join our permanent team. As a key member of our academic community, you will...


  • Cambridge, Cambridgeshire, United Kingdom Hologic, Inc. Full time

    Job Title: Senior Director of Quality AssuranceCompany: Hologic, Inc.Location: GlobalPosition Overview:We are seeking an accomplished and strategic Senior Director of Quality Assurance to lead our quality assurance and control initiatives to ensure compliance with global QMS and regulations. This key leadership role sits on the international business...