Quality Assurance Manager

2 months ago


London, Greater London, United Kingdom Regulatory and Quality Solutions LLC (R&Q) Full time
Job Title: Quality Assurance Manager

Regulatory and Quality Solutions LLC (R&Q) is seeking a highly skilled Quality Assurance Manager to join our team. As a Quality Assurance Manager, you will be responsible for developing and improving Quality systems in compliance with requirements through auditing, gap assessment, remediation, and including management and support of Corrective/Preventive actions, Recall, Complaints, etc.

Key Responsibilities:
  • Develop/contribute to Quality System development: ISO 13485, QSR, MDSAP, 21 CFR 820, GMP
  • Improve/remediation Quality systems through development and or revision of elements of the QMS to meet standards or new requirements Usability, ISO 13485:2016, EU MDR, GMP, safety risk management, rd edition
  • Write/improve and train others on SOPs
  • Perform gap assessments to prepare for external audits/FDA inspections
  • Support external audits
  • Coordinate and conduct internal audits
  • FDA inspection readiness and support
  • Conduct EU MDR mock NB audits
  • Coordinate and conduct Supplier quality audits
  • Select and qualify suppliers
  • Create/Maintain Authorize Supplier List (ASL) or scorecards
  • Draft Supplier Agreements
  • Train others on Supplier Quality
  • Develop SOPs for Supplier Quality
Key Requirements:
  • Bachelor's Degree in relevant subject
  • Experience working within medical/diagnostic device in a quality role in industry
  • Working knowledge of requirements such as 21 CFR 820, ISO 13485 and GMP
  • Working knowledge of standards such as: ISO 13485:2016, EU MDR, GMP, safety risk management, rd edition
  • FDA Regulatory requirements, the EU Medical Device
  • Experience with MDSAP audits


  • London, Greater London, United Kingdom Quality Enterprises USA Full time

    Quality and Regulatory EngineerJoin Quality Enterprises USA in a challenging role that combines quality assurance and regulatory expertise. As a Quality and Regulatory Engineer, you will be responsible for ensuring compliance with industry standards and regulations, such as FDA and ISO.Key Responsibilities:Develop and implement quality assurance processes...


  • London, Greater London, United Kingdom Quality Enterprises USA Full time

    Quality and Regulatory EngineerJoin Quality Enterprises USA in a challenging role that combines quality assurance and regulatory expertise. As a Quality and Regulatory Engineer, you will be responsible for ensuring compliance with industry standards and regulations, such as FDA and ISO.Key Responsibilities:Develop and implement quality assurance processes...


  • London, Greater London, United Kingdom Quality Enterprises USA Full time

    Quality and Regulatory EngineerJoin Quality Enterprises USA in a challenging role that combines quality assurance and regulatory expertise. As a Quality and Regulatory Engineer, you will be responsible for ensuring compliance with industry standards and regulations, such as FDA and ISO.Key Responsibilities:Develop and implement quality assurance processes...


  • London, Greater London, United Kingdom Quality Enterprises USA Full time

    Quality and Regulatory EngineerJoin Quality Enterprises USA in a challenging role that combines quality assurance and regulatory expertise. As a Quality and Regulatory Engineer, you will be responsible for ensuring compliance with industry standards and regulations, such as FDA and ISO.Key Responsibilities:Develop and implement quality assurance processes...


  • London, Greater London, United Kingdom Quality Enterprises USA Full time

    At Quality Enterprises USA, we're seeking a highly skilled National Quality Assurance Manager to join our team. As a key member of our National Quality Assurance Team, you'll be responsible for ensuring the highest standards of quality and technical compliance across our projects.The RoleAs a National Quality Assurance Manager, you'll be responsible for...


  • London, Greater London, United Kingdom Quality Enterprises USA Full time

    At Quality Enterprises USA, we are seeking a highly skilled Quality Assurance Specialist to join our team. The ideal candidate will have a strong understanding of regulatory requirements and industry standards, as well as excellent problem-solving and analytical skills.Responsibilities:Proficiency in root cause analysis techniques and CAPA managementStrong...


  • London, Greater London, United Kingdom Quality Enterprises USA Full time

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Quality Enterprises USA.The ideal candidate will have a minimum of 4-6 years of experience in quality assurance, with a strong background in process validation and regulatory compliance.Responsibilities:Develop and implement quality assurance policies and...


  • London, Greater London, United Kingdom Quality Enterprises USA Full time

    Quality and Regulatory EngineerAt Quality Enterprises USA, we are seeking a highly skilled Quality and Regulatory Engineer to join our team.Key Responsibilities:Proficiency in root cause analysis techniques and CAPA management.Strong understanding of regulatory requirements (e.g., FDA, ISO) and industry standards.Excellent problem-solving, analytical, and...


  • London, Greater London, United Kingdom Quality Personnel Full time

    Quality Control Co-ordinator Job DescriptionWe are seeking a highly skilled Quality Control Co-ordinator to join our team at Quality Personnel. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality in our products and services.Key Responsibilities:Oversee and update our Quality Management System to ensure...


  • London, Greater London, United Kingdom Quality Personnel Full time

    Quality Control Co-ordinator Job DescriptionWe are seeking a highly skilled Quality Control Co-ordinator to join our team at Quality Personnel. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality in our products and services.Key Responsibilities:Oversee and update our Quality Management System to ensure...


  • London, Greater London, United Kingdom Quality Personnel Full time

    Quality Control Co-ordinatorWe are seeking a highly skilled Quality Control Co-ordinator to join our team at Quality Personnel. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality in our products and services.Key Responsibilities:Oversee and update our Quality Management System to ensure compliance with...


  • London, Greater London, United Kingdom Quality Personnel Full time

    Quality Control Co-ordinatorWe are seeking a highly skilled Quality Control Co-ordinator to join our team at Quality Personnel. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality in our products and services.Key Responsibilities:Oversee and update our Quality Management System to ensure compliance with...


  • London, Greater London, United Kingdom Birkbeck University of London Full time

    We are seeking an experienced Quality Assurance Manager to lead on quality assurance and enhancement in higher education. The successful candidate will have significant experience in managing quality assurance and enhancement, particularly data-driven approaches to quality.The Quality Assurance Manager will lead the strategic development of the University's...


  • London, Greater London, United Kingdom Baltimore Consulting Limited Full time £350

    SEND Quality Assurance Manager We are seeking an experienced SEND Quality Assurance Manager to join our team at Baltimore Consulting Limited. As a SEND Quality Assurance Manager, you will be responsible for managing and overseeing the SEND Quality Assurance Framework and processes, ensuring consistency and high standards in EHCPs. Your key responsibilities...


  • London, Greater London, United Kingdom Birkbeck University of London Full time

    Job Title: Quality Assurance ManagerBirkbeck, University of London, is seeking an experienced Quality Assurance Manager to lead on quality assurance and enhancement, including collaborative provision.This role is based within Academic Standards and Quality, part of the new Education and Student Experience Directorate, and you would work closely with academic...


  • London, Greater London, United Kingdom Birkbeck University of London Full time

    Job Title: Quality Assurance ManagerBirkbeck, University of London, is seeking an experienced Quality Assurance Manager to lead on quality assurance and enhancement, including collaborative provision.This role is based within Academic Standards and Quality, part of the new Education and Student Experience Directorate, and you would work closely with academic...


  • London, Greater London, United Kingdom RBW Consulting Full time

    **Quality Assurance Manager**RBW Consulting is seeking a highly skilled Quality Assurance Manager to join our team. As a Quality Assurance Manager, you will be responsible for leading a small team and overseeing all aspects of quality assurance.The ideal candidate will have experience working in a GMP environment and possess strong leadership and management...


  • London, Greater London, United Kingdom Millbank Holdings Full time

    Quality Assurance and Control LeadMillbank Holdings Ltd is seeking an experienced Quality Assurance and Control Lead to join their team of nuclear specialists. The successful candidate will be responsible for ensuring supply-chain adherence to quality assurance and control requirements, as well as supporting the Quality Director and Quality Delivery Managers...


  • London, Greater London, United Kingdom Millbank Holdings Full time

    Quality Assurance and Control LeadMillbank Holdings Ltd is seeking an experienced Quality Assurance and Control Lead to join their team of nuclear specialists. The successful candidate will be responsible for ensuring supply-chain adherence to quality assurance and control requirements, as well as supporting the Quality Director and Quality Delivery Managers...


  • London, Greater London, United Kingdom Millbank Holdings Full time

    Quality Assurance and Control ExpertiseWe are seeking an experienced Quality Assurance and Control professional to join our team at Millbank Holdings Ltd. As a Quality Assurance Manager, you will be responsible for ensuring that our projects meet the highest quality standards.Key Responsibilities:Develop and implement quality assurance and control plans...