Global Quality Assurance and Regulatory Affairs Systems Manager

2 weeks ago


Bedford, Bedford, United Kingdom Werfen Full time

Overview

Werfen

At Werfen, we are a growing, family-owned, innovative company founded in Barcelona, Spain. As a worldwide leader in specialized diagnostics, we strive for excellence in Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Our commitment to innovation and quality drives us to develop customized assays and biomaterials through our Original Equipment Manufacturing (OEM) business line.

We operate directly in 30 countries and in more than territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Job Summary

The Global QA/RA Systems Manager will provide leadership, planning, and project coordination to develop a cost-effective electronic Quality Management Systems (eQMS) and harmonized QA/RA information systems. This role will facilitate efficient operations to meet current and future business needs by collaborating with QA/RA partners, IT, and outside vendors.

Responsibilities

  • Develop a global strategy for the implementation, maintenance, operations, and optimization of the eQMS platforms.
  • Leverage synergies between processes and workflows in the different Technology Centers and promote standardization/harmonization to the extent possible.
  • Lead the Digital Board QARA meetings from the QA/RA side.
  • Conduct and participate in the analysis of workflows and design of functionality and/or improvements to systems.
  • Identify opportunities for process improvement, automation, application operational efficiency, and security.
  • Work cross-functionally to understand business needs and provide actionable insights for ongoing stakeholders needs.


  • Bedford, Bedford, United Kingdom Werfen Full time

    OverviewWerfenWerfen is a global leader in the development, manufacturing, and distribution of specialized diagnostic instruments, reagents, and data management solutions. With a strong focus on innovation and quality, we provide healthcare professionals with valuable and complete solutions to improve hospital efficiency and enhance patient care. Our...


  • Bedford, Bedford, United Kingdom Werfen Full time

    OverviewWerfen, a global leader in diagnostic instruments, seeks a highly skilled Regulatory Affairs Specialist to join our team. This role will focus on ensuring compliance with regulatory requirements for our medical devices in international markets.Key ResponsibilitiesDevelop and implement regulatory strategies to satisfy NMPA and PMDA...


  • Bedford, Bedford, United Kingdom Werfen Full time

    OverviewWerfenWerfen is a global leader in the development, manufacturing, and distribution of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories.The Company's business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics,...


  • Bedford, Bedford, United Kingdom Werfen Full time

    OverviewWerfenWerfen is a global leader in the development, manufacturing, and distribution of specialized diagnostic instruments, reagents, and data management solutions for hospitals and clinical laboratories. Our business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. We prioritize...


  • Bedford, Bedford, United Kingdom Werfen Full time

    Job Summary:Werfen is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for our medical devices in China and Japan.Key Responsibilities:Participate in design and risk management teams to provide guidance on regulatory...


  • Bedford, Bedford, United Kingdom Lantheus Medical Imaging Inc Full time

    Regulatory Affairs SpecialistLantheus Medical Imaging Inc is a leading company in the field of medical imaging. We are seeking an experienced Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong background in regulatory affairs, with a focus on labeling and promotional communications. The successful candidate will be...


  • Bedford, Bedford, United Kingdom Werfen Full time

    OverviewWerfen is a global developer, manufacturer, and distributor of specialized diagnostic instruments, reagents, automation workcells, and data management solutions. Our business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics. We focus on providing valuable and complete solutions to improve hospital efficiency and enhance patient...


  • Bedford, Bedford, United Kingdom Werfen Full time

    Job OverviewWerfen - Leading in Diagnostic SolutionsAt Werfen, we are a world-leading company in specialized diagnostics, committed to innovation and quality. We strive to provide healthcare professionals with the most valuable and complete solutions to improve hospital efficiency and enhance patient care.Key ResponsibilitiesWe are seeking a skilled and...


  • Bedford, Bedford, United Kingdom Werfen Full time

    About WerfenWerfen is a global leader in the development, manufacturing, and distribution of specialized diagnostic instruments, reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories.The Company's business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well...

  • Program Manager I

    4 weeks ago


    Bedford, Bedford, United Kingdom Werfen Full time

    OverviewWerfenWerfen is a growing, family-owned, innovative company founded in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized...


  • Bedford, Bedford, United Kingdom Werfen Full time

    Job Summary:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Werfen. As a key member of our regulatory team, you will be responsible for ensuring compliance with China NMPA and Japan PMDA regulations for our medical devices.Key Responsibilities:Participate in design and risk management teams to provide guidance on regulatory...


  • Bedford, Bedford, United Kingdom RGS Global Full time

    RGS Global is seeking a highly skilled Manufacturing Quality Engineer to join their team.About the RoleWe are looking for an experienced Manufacturing Quality Engineer to lead our manufacturing process steps for the assembly of Printed Circuit Boards (PCBs) and ensure products meet customer expectations. The ideal candidate will have a strong background in...


  • Bedford, Bedford, United Kingdom Lantheus Medical Imaging Inc Full time

    Lantheus Medical Imaging Inc is a leader in pioneering the field of medical imaging. As a forward-thinking organization, we're seeking a seasoned professional to lead the development of regulatory labeling and promotional materials.Key ResponsibilitiesCollaborate with cross-functional teams to create promotional and disease awareness communications, field...


  • Bedford, Bedford, United Kingdom Lantmännen Unibake Full time

    Job Title: Quality AuditorReporting To: Quality SupervisorShift: Pink ShiftAs a Quality Auditor, you will play a vital role in ensuring that our food products consistently meet the highest standards of safety and quality. Your meticulous attention to detail and expertise in food safety regulations will ensure that our manufacturing processes comply with...


  • Bedford, Bedford, United Kingdom Resourcing Global Solutions Full time

    The Electronics Quality Assurance Specialist will be responsible for ensuring the highest quality standards in the production of electronic printed circuit boards. The ideal candidate will have a strong background in quality control and be familiar with IPC standards.Main Responsibilities:Inspect and test electronic components to ensure they meet quality...


  • Bedford, Bedford, United Kingdom Werfen Full time

    Job SummaryThe Global QA/RA Systems Manager at Werfen is responsible for providing leadership and planning to develop a cost-effective electronic Quality Management Systems (eQMS) and harmonized QA/RA information systems. This role requires collaboration with QA/RA partners, IT teams, and outside vendors to develop efficient processes and workflows. The...


  • Bedford, Bedford, United Kingdom Werfen Full time

    OverviewWerfenWerfen is a leading company in specialized diagnostics, operating in 30 countries and serving over 7,000 customers worldwide. Our innovative solutions are designed to improve hospital efficiency and enhance patient care.Job SummaryThe Global QA/RA Systems Manager is responsible for providing leadership and management to develop and implement a...


  • Bedford, Bedford, United Kingdom Resourcing Global Solutions Full time

    Electronics Quality Assurance SpecialistThe successful candidate will be responsible for ensuring the quality of electronic components and printed circuit boards, adhering to IPC standards and working with microscopes.Main Responsibilities:Minimum 12 months of experience in electronic printed circuit board assembly to IPC 610 class 3Proficiency in working...


  • Bedford, Bedford, United Kingdom Supersede Recruitment Partners Full time

    Quality Auditor RoleSupersede Recruitment Partners is seeking a Quality Auditor to join their successful technical team at a market leading food manufacturer.The main focus of the role is to ensure the quality, safety, and legality of all products throughout the manufacturing process, while meeting both company and regulatory authorities' standards.Key...


  • Bedford, Bedford, United Kingdom Vickerstock Full time

    Vickerstock is seeking a highly skilled Technical Manager to join their team. As a key member of the operations team, you will be responsible for ensuring the highest standards of quality and safety in the production of meat products.Key Responsibilities:Design, implement, and maintain a HACCP based Quality Management SystemMonitor and improve factory...