Senior Quality Assurance Manager

6 days ago

Oxford, Oxfordshire, United Kingdom SciPro Full time

**About SciPro**

We are a leading provider of innovative medical solutions, specializing in AI-powered imaging biomarkers. As an exclusive partner of Brainomix, we are committed to delivering high-quality products that meet the highest regulatory standards.

**Job Summary**

We are seeking a highly experienced Senior Quality Assurance Manager to join our team. As a key member of our leadership team, you will be responsible for overseeing the quality management system, ensuring compliance with regulatory requirements, and driving continuous improvement.

**Key Responsibilities**

  • **Lead the Quality Function**: Oversee the quality management system, ensuring it is aligned with regulatory requirements and industry best practices.
  • **Regulatory Compliance**: Maintain current FDA, CE, and other regulatory clearances, and lead regulatory submission efforts for new products.
  • **Quality Management System**: Oversee the implementation and maintenance of the company's Quality Management System (QMS).
  • **Internal and External Audits**: Ensure compliance through internal and external audits, and implement corrective actions as necessary.
  • **Collaboration**: Collaborate with Clinical, R&D, Development, Marketing, and Technical Support teams to ensure regulatory compliance throughout the product lifecycle.
  • **Leadership**: Serve as the most senior Regulatory/QA leader within the business, providing guidance and support to team members.

**Requirements**

  • **Education**: Degree in a scientific field.
  • **Experience**: Minimum 4 years' experience in regulatory affairs within the medical device industry.
  • **Regulatory Affairs**: Experience in SaMD regulatory affairs or software integrated into active medical devices.
  • **Documentation**: Proven track record in drafting, compiling, and submitting technical documentation for CE certification.
  • **Regulatory Authorities**: Experience in liaising with regulatory authorities and Notified Bodies, including negotiation.
  • **Regulatory Processes**: Hands-on experience with regulatory processes and submissions under MDR.
  • **Clinical Evidence**: Involvement in development and clinical evidence activities to ensure regulatory compliance.
  • **Communication**: Ability to translate, summarize, and clarify technical and scientific information for both internal and external communication.

**Nice to Have**

  • **Clinical Evidence**: Knowledge of Clinical Evidence and Clinical Evaluation Report (CER) requirements.
  • **PMS**: Understanding of PMS requirements.
  • **Medical Device Regulations**: Knowledge of medical device regulatory requirements.

  • Senior Quality Assurance Manager

    2 days ago

    Oxford, Oxfordshire, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job Title: Senior Quality Assurance ManagerJob Summary:We are seeking a highly skilled Senior Quality Assurance Manager to join our team at Pharma Partners Recruitment Ltd. As a Senior Quality Assurance Manager, you will be responsible for ensuring the quality and compliance of our products and processes.Key Responsibilities:Develop and implement quality...

  • Senior Quality Assurance Manager

    2 days ago

    Oxford, Oxfordshire, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job Title: Senior Quality Assurance ManagerJob Summary:We are seeking a highly skilled Senior Quality Assurance Manager to join our team at Pharma Partners Recruitment Ltd. As a Senior Quality Assurance Manager, you will be responsible for ensuring the quality and compliance of our products and processes.Key Responsibilities:Develop and implement quality...

  • Senior Quality Assurance Manager

    5 hours ago

    Oxford, Oxfordshire, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job Title: Senior Quality Assurance ManagerJob Summary:We are seeking a highly skilled Senior Quality Assurance Manager to join our team at Pharma Partners Recruitment Ltd. As a Senior Quality Assurance Manager, you will be responsible for ensuring the quality and compliance of our products and processes.Key Responsibilities:Coordinate and manage the...

  • Senior Quality Assurance Manager

    2 hours ago

    Oxford, Oxfordshire, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job Title: Senior Quality Assurance ManagerJob Summary:We are seeking a highly skilled Senior Quality Assurance Manager to join our team at Pharma Partners Recruitment Ltd. As a Senior Quality Assurance Manager, you will be responsible for ensuring the quality and compliance of our products and processes.Key Responsibilities:Coordinate and manage the...

  • Quality Assurance Manager

    4 days ago

    Oxford, Oxfordshire, United Kingdom Rise Technical Recruitment Limited Full time

    Job Summary:Rise Technical Recruitment Limited is seeking a highly skilled Quality Assurance Manager to join our team. As a Quality Assurance Manager, you will be responsible for ensuring site Quality systems are adhered to, leading audits, and being the most Senior member of the QA team.About the Role:Ensure site Quality systems are adhered toLead audits...

  • Quality Assurance Manager

    6 days ago

    Oxford, Oxfordshire, United Kingdom Rise Technical Recruitment Limited Full time

    Job Summary:Rise Technical Recruitment Limited is seeking a highly skilled Quality Assurance Manager to join our team. As a Quality Assurance Manager, you will be responsible for ensuring site Quality systems are adhered to, leading audits, and being the most Senior member of the QA team.About the Role:Ensure site Quality systems are adhered toLead audits...

  • Quality Assurance Manager

    2 weeks ago

    Oxford, Oxfordshire, United Kingdom allen-associates Full time

    Quality Assurance Manager Job OpportunityAllen Associates is seeking a highly skilled Quality Assurance Manager to join our team in Oxford. As a Quality Assurance Manager, you will be responsible for overseeing the company's quality requirements, including day-to-day operations, process reviews, internal audits, and transitioning to new ISO...

  • Senior Quality Assurance Manager

    5 days ago

    Oxford, Oxfordshire, United Kingdom SciPro Full time

    About the RoleWe are seeking a highly experienced Senior Quality Assurance Manager to join our team at SciPro, a leading partner of Brainomix. As a key member of our organization, you will be responsible for overseeing the Quality Management System (QMS) and ensuring compliance through internal and external audits.Key ResponsibilitiesLead the function to...

  • Senior Quality Assurance Manager

    5 days ago

    Oxford, Oxfordshire, United Kingdom SciPro Full time

    **About SciPro**We are a leading provider of innovative solutions in the medical device industry, specializing in AI-powered imaging biomarkers. Our mission is to drive growth and excellence in our partnerships, and we are seeking a highly skilled Senior Quality Assurance Manager to join our team.**Job Summary**We are looking for a seasoned professional to...

  • Senior Quality Assurance Director

    3 hours ago

    Oxford, Oxfordshire, United Kingdom Planet Pharma Full time

    About the RoleWe are seeking a highly experienced and skilled Senior Quality Assurance Director to join our team at Planet Pharma. As a key member of our organization, you will be responsible for developing and leading our Quality Assurance function to ensure the highest standards of quality and compliance.Key ResponsibilitiesDevelop and implement a quality...

  • Senior Quality Assurance Director

    19 minutes ago

    Oxford, Oxfordshire, United Kingdom Planet Pharma Full time

    About the RoleWe are seeking a highly experienced and skilled Senior Quality Assurance Director to join our team at Planet Pharma. As a key member of our organization, you will be responsible for developing and leading our Quality Assurance function to ensure the highest standards of quality and compliance.Key ResponsibilitiesDevelop and implement a quality...

  • Senior Quality Assurance Manager

    4 days ago

    Oxford, Oxfordshire, United Kingdom SciPro Full time

    SciPro is proud to be an exclusive partner of Brainomix, a renowned business specializing in AI-powered imaging biomarkers. To facilitate their journey of growth, they are seeking a Senior Quality Assurance Manager to oversee a team of 5, who is able to promote collaboration rather than adopting a dictatorial approach. The ideal candidate will have a...

  • Senior Quality Assurance Manager

    4 days ago

    Oxford, Oxfordshire, United Kingdom SciPro Full time

    SciPro is proud to be an exclusive partner of Brainomix, a renowned business specializing in AI-powered imaging biomarkers. To facilitate their journey of growth, they are seeking a Senior Quality Assurance Manager to oversee a team of 5, who is able to promote collaboration rather than adopting a dictatorial approach. The ideal candidate will have a...

  • Senior Quality Assurance Manager

    2 days ago

    Oxford, Oxfordshire, United Kingdom SciPro Full time

    About the RoleWe are seeking a highly experienced Senior Quality Assurance Manager to join our team at SciPro, a leading provider of innovative medical device solutions. As a key member of our organization, you will be responsible for leading our Quality Management System (QMS) and ensuring compliance with regulatory requirements.Key ResponsibilitiesLead the...

  • Senior Quality Assurance Manager

    2 days ago

    Oxford, Oxfordshire, United Kingdom SciPro Full time

    About the RoleWe are seeking a highly experienced Senior Quality Assurance Manager to join our team at SciPro, a leading provider of innovative medical device solutions. As a key member of our organization, you will be responsible for leading our Quality Management System (QMS) and ensuring compliance with regulatory requirements.Key ResponsibilitiesLead the...

  • Senior Quality Assurance Manager

    3 days ago

    Oxford, Oxfordshire, United Kingdom SciPro Full time

    SciPro is proud to be an exclusive partner of Brainomix, a renowned business specializing in AI-powered imaging biomarkers. To facilitate their journey of growth, they are seeking a Senior Quality Assurance Manager to oversee a team of 5, who is able to promote collaboration rather than adopting a dictatorial approach. The ideal candidate will have a...

  • Senior Quality Assurance Manager

    3 days ago

    Oxford, Oxfordshire, United Kingdom SciPro Full time

    SciPro is proud to be an exclusive partner of Brainomix, a renowned business specializing in AI-powered imaging biomarkers. To facilitate their journey of growth, they are seeking a Senior Quality Assurance Manager to oversee a team of 5, who is able to promote collaboration rather than adopting a dictatorial approach. The ideal candidate will have a...

  • Senior Quality Assurance Manager

    6 days ago

    Oxford, Oxfordshire, United Kingdom Planet Pharma Full time

    About the RoleWe are seeking a highly experienced and skilled Director of Quality Assurance and Compliance to join our team at Planet Pharma. As a key member of our organization, you will be responsible for developing and leading our Quality Assurance function to ensure compliance with regulatory requirements and industry standards.Key...

  • Senior Quality Assurance Engineer

    7 hours ago

    Oxford, Oxfordshire, United Kingdom CT19 Full time

    Job Description**Job Title:** Senior Quality Assurance Engineer**Company:** CT19**Job Type:** Full-time**Location:** Remote (with occasional on-site visits)**About Us:CT19 is a pioneering start-up in the analytical instruments industry, providing vital insights for scientific discovery, R&D, and therapeutics production. With over 350 instruments installed in...

  • Senior Quality Assurance Engineer

    5 hours ago

    Oxford, Oxfordshire, United Kingdom CT19 Full time

    Job Description**Job Title:** Senior Quality Assurance Engineer**Company:** CT19**Job Type:** Full-time**Location:** Remote (with occasional on-site visits)**About Us:CT19 is a pioneering start-up in the analytical instruments industry, providing vital insights for scientific discovery, R&D, and therapeutics production. With over 350 instruments installed in...