Quality Engineer – Compliance

3 weeks ago

Cambridge UK, Cambridgeshire, United Kingdom TekWissen UK Full time

Position Title: Quality Engineer – Compliance

Location: Cambridge, UK (2-3 days on-site per week)

Work Hours: 37 hours per week


Job Overview:

The Quality Engineer – Compliance will be responsible for providing design control and risk management expertise to medical device and combination product development programs throughout the product lifecycle. This includes the generation and review of design history and risk management file components, as well as collaboration with cross-functional development teams.


Key Responsibilities:

  • Design Control & Risk Management:
  • Lead and manage design control and risk management activities for combination product development programs.
  • Ensure deliverables are compliant with clinical trials and commercial licensure requirements.
  • Facilitate risk management activities with external design companies and manufacturing facilities.
  • Compliance & Validation:
  • Ensure product development activities comply with internal and external quality and regulatory standards.
  • Provide input and support for design validation, including human factors engineering assessments.
  • Support regulatory submission data generation for assigned device projects.
  • Supplier & Manufacturing Support:
  • Assess external design companies and suppliers' capabilities related to device development and supply.
  • Support device design and manufacturing investigations during clinical trials and commercial manufacture.
  • Audit & Quality Management:
  • Assist in internal and external audits of the DCoE Quality Management System.

Educational & Experience Requirements:

  • Qualifications:
  • BSc, MSc, or PhD in a relevant science or engineering discipline (e.g., chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering).
  • Experience:
  • Minimum 2 years of relevant experience in the pharmaceutical combination product and/or device industries.
  • Experience in design controls and risk management for combination products.
  • Familiarity with ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and EU Medical Devices Regulation.

Technical Skills:

  • Proficient in ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and EU Medical Devices Regulation.
  • Knowledgeable in EN 62366, EN 60601, and EN 62304 standards.
  • Familiar with Human Factors Engineering and device assembly manufacturing processes.
  • Strong attention to technical details and accuracy.
  • Ability to work independently and prioritize multiple tasks.

Competencies:

  • Decisive: Agile learner with the ability to synthesize complex information.
  • Focused: Accountable for meeting the needs of customers and stakeholders.
  • Connected: Effective in building professional relationships with stakeholders.
  • Courageous: Consistent and trustworthy in actions and decisions.
  • Resilient: Adaptable to shifting priorities in response to organizational needs.

Physical Requirements:

  • Ability to sit for extended periods.
  • Willingness and ability to travel.
  • Possession of a valid driving license.

  • Quality Engineer

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom Marshall Group Full time

    About the RoleWe are seeking a highly skilled and experienced Quality Engineer - Special Processes to join our team at Marshall Group. As a key member of our Quality Assurance team, you will play a critical role in ensuring the highest standards of quality and compliance across our special processes.Key ResponsibilitiesQuality Assurance and Compliance:...

  • Quality Engineer

    6 days ago

    Cambridge, Cambridgeshire, United Kingdom Marshall Group Full time

    About the RoleWe are seeking a highly skilled and experienced Quality Engineer - Special Processes to join our team at Marshall Group. As a key member of our Quality Assurance team, you will play a critical role in ensuring the highest standards of quality and compliance across our special processes.Key ResponsibilitiesQuality Assurance and Compliance:...

  • Quality Engineer

    2 weeks ago

    Cambridge, UK, Cambridgeshire, United Kingdom Russell Tobin Full time

    Quality Engineer - 12 months contract - Cambridge (Hybrid) - upto £24 per hour UmbrellaResponsibilities:Lead design control and risk management activities for combination product development programs, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.Support and facilitation of...

  • Quality and Compliance Manager

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full time

    About 52North - Creators of Neutrocheck52North is a leading med-tech company that aims to revolutionize healthcare journeys for people worldwide. As a pioneer in innovative healthcare solutions, we are committed to integrating cutting-edge technology with a human-centered approach to improve patient experiences and set new industry standards.Our MissionWe...

  • Compliance and Quality Manager

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Harris Lord Life Sciences Full time

    Quality Assurance ManagerCompany: Harris Lord Life SciencesSalary: £60kAre you ready to elevate your career in a transformative medical organization?Join a forward-thinking company dedicated to enhancing the detection and management of significant health conditions such as cancer, neurological disorders, and infectious diseases. This is your chance to make...

  • Quality Assurance Engineer

    3 days ago

    Cambridge, Cambridgeshire, United Kingdom TekWissen UK Full time

    Job Title: Quality Assurance Engineer – ComplianceLocation: Remote (2-3 days on-site per week)Work Hours: 37 hours per weekJob Overview:The Quality Assurance Engineer – Compliance will be responsible for providing design control and risk management expertise to medical devices and combination product development programs throughout the product lifecycle....

  • Quality Assurance Engineer

    3 days ago

    Cambridge, Cambridgeshire, United Kingdom TekWissen UK Full time

    Job Title: Quality Assurance Engineer – ComplianceLocation: Remote (2-3 days on-site per week)Work Hours: 37 hours per weekJob Overview:The Quality Assurance Engineer – Compliance will be responsible for providing design control and risk management expertise to medical devices and combination product development programs throughout the product lifecycle....

  • Quality Assurance and Compliance Lead

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom TEAM Full time

    Join Our Team as a Quality Assurance and Compliance Lead Are you eager to contribute to the advancement of digital diagnostics? We are on the lookout for a Quality Assurance & Compliance Lead who is dedicated to enhancing quality and compliance within a dynamic and innovative setting. If you possess a meticulous attention to detail and a robust background in...

  • Quality Assurance Engineer

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Platform Recruitment Full time £50,000 - £55,000

    Role Overview As a Quality Assurance Engineer, you will play a crucial role in collaborating with the Hardware team to ensure the successful execution of development initiatives. Key Responsibilities Evaluation and Verification: Conduct thorough testing and validation processes for products and designs that utilize radio frequency (RF)...

  • Regulatory Compliance Engineer

    6 days ago

    Cambridge, Cambridgeshire, United Kingdom CK Group Full time

    Job DescriptionCK Group is seeking a highly skilled Quality Engineer to join their team in the Pharmaceutical industry. This contract role is based in Cambridge and will last for 12 months.Key Responsibilities:Design Control and Risk Management: Lead design control and risk management activities for combination product development programs.External...

  • Regulatory Compliance Engineer

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom CK Group Full time

    Job DescriptionCK Group is seeking a highly skilled Quality Engineer to join their team in the Pharmaceutical industry. This contract role is based in Cambridge and will last for 12 months.Key Responsibilities:Design Control and Risk Management: Lead design control and risk management activities for combination product development programs.External...

  • Quality Assurance and Compliance Leader

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom TEAM Full time

    Position OverviewAre you prepared to significantly influence the realm of digital diagnostics? We are in search of a Quality Assurance & Compliance Leader who is dedicated to enhancing quality and compliance within a dynamic and innovative setting. If you possess a meticulous attention to detail and a robust understanding of ISO standards, this position...

  • Quality Assurance and Compliance Lead

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom TEAM Full time

    Are you eager to contribute significantly to the realm of digital diagnostics? We are on the lookout for a Quality Assurance & Compliance Lead who is dedicated to enhancing quality and compliance within a dynamic and innovative setting. If you possess a meticulous eye for detail and a robust background in ISO standards, this position presents an excellent...

  • Regulatory Compliance Professional

    6 days ago

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

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Newton Colmore Consulting Ltd. As a Quality Engineer, you will play a critical role in ensuring the quality and safety of our Medical Devices.Key ResponsibilitiesCollaborate with cross-functional teams, including Mechanical Engineers, Physicists, Electronics...

  • Regulatory Compliance Professional

    1 week ago

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

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Newton Colmore Consulting Ltd. As a Quality Engineer, you will play a critical role in ensuring the quality and safety of our Medical Devices.Key ResponsibilitiesCollaborate with cross-functional teams, including Mechanical Engineers, Physicists, Electronics...

  • Head of Digital Quality Assurance and Compliance

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom Harris Lord Life Sciences Full time

    Job DescriptionQuality and Compliance Manager£60kWe are seeking a highly skilled Quality and Compliance Manager to join our team at Harris Lord Life Sciences. As a key member of our organization, you will be responsible for driving quality and compliance in a fast-paced, innovative environment.Key Responsibilities:Quality Management System (QMS) Leadership:...

  • Lead Quality Control Engineer

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Falcon Green Personnel Full time £70,000

    Position OverviewFalcon Green Personnel is currently seeking a qualified and experienced Quality Control Manager to oversee service installations within a variety of residential projects. The role will involve managing substantial MEP packages, ensuring that all installations meet the highest standards of quality and compliance.Key ResponsibilitiesOversee...

  • Special Processes Quality Assurance Engineer

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom Marshall Group Full time

    About the RoleWe are seeking a highly skilled Quality Engineer - Special Processes to join our team at Marshall Group. As a Quality Engineer - Special Processes, you will play a key role in ensuring the quality of our products and services, and will be responsible for leading internal and external audits, as well as implementing corrective and preventive...

  • Special Processes Quality Assurance Engineer

    6 days ago

    Cambridge, Cambridgeshire, United Kingdom Marshall Group Full time

    About the RoleWe are seeking a highly skilled Quality Engineer - Special Processes to join our team at Marshall Group. As a Quality Engineer - Special Processes, you will play a key role in ensuring the quality of our products and services, and will be responsible for leading internal and external audits, as well as implementing corrective and preventive...

  • Senior Manager, Device Quality and Compliance

    2 days ago

    Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    Job SummaryWe are seeking a highly experienced Senior Manager, Device Quality and Compliance to join our team at MoonLake Immunotherapeutics. As a key member of our Quality Team, you will be responsible for defining and implementing a Device Quality Management System (QMS) that meets regulatory requirements and ensures the quality of our drug-device...