Manager, Quality Assurance

CooperVision

  • Venlo, Limburg
  • Vast
  • Voltijds
  • 24 dagen geleden
Job Category: Quality ManagementJob Description:CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values - dedicated, innovative, friendly, partners, and do the right thing - our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women's and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more atResponsibilities:#LI-OnsiteAt CooperSurgical we are currently looking to recruit a Quality Manager- for our Distribution Center (DC). In this role there will be one direct report and much cross- functional collaboration and stakeholder management with local, regional, and corporate CSI organizations.You will be part of the CooperSurgical Regional Quality team, with direct reference to the Director of Quality Assurance OUS manufacturing, distribution, and service. The role is placed in Venlo, Netherland and is onsite.Applicants must be eligible to work in Netherland and travel freely in EU, UK and APAC.PositionAs Quality Manager, you will play a critical role in ensuring regulatory compliance, implementation, continuous improvements, and consistent performance of CSI quality management system requirements at Venlo DC site.In this role, you will be the Quality subject matter expert of the end-to-end finished goods supply chain, enabling the distribution quality standards and regulatory compliance for the EMEA and part of APAC regions.The Quality manager is responsible for providing quality oversight for area specific change controls, deviations and CAPAs and participate in and reviewing investigations.It's essential to ensuring that products received/stored/labeled/shipped from Venlo DC meet the required quality standards and customers' expectations, in compliance with the requirements of the European (MDR) Medical Device Regulation 2017 / 745 on medical devices, European In Vitro Diagnostic Regulation (IVDR) 2017/ 746, ISO 13485 standard, including FDA CFR Part 820 Quality System Regulation.As CooperSurgical have satellite distribution centers in Turkey, Australia /NZ and India, its important to work closely with these countries and be familiar with their local regulations.This position requires a seasoned professional with a deep understanding of GMP, GSP, and GDP practices, excellent problem-solving skills, and the ability to collaborate across cross-functional teams.You thrive in a dynamic environment and are comfortable juggling several complex tasks while keeping an eye on the details. You will work closely together with the Quality and Regulatory teams and relevant stakeholders, globally.Your key responsibilities
  • Ensure maintenance of site quality systems in a state of control by ensuring continuous adherence to Good Manufacturing, Distribution and Service Practices.
  • Develop a culture of continuous improvement by developing and implementing strategies that achieve measurable results such lowering product scrap and returns.
  • Establish and maintain quality assurance procedures to ensure products meet required GXP
  • Ensure documentation and filing according to industry standard
  • Develop, establish, and monitor KPIs and drive initiatives to improve this quality metrics at the Distribution Center.
  • Conduct internal and external audits
Qualifications:
  • MSc in Science or Engineering
  • + 5 years of experience from a similar role managerial role, preferable within medical device or pharmaceutical
  • +7 years managing a Quality management system
  • Experience with an international set-up
  • Problem-solving, structured, and systematic approach
  • Good communicator and team player
  • Robust and flexible mindset
  • Proficient level in MS office
  • Fluent English (spoken and written) is mandatory

CooperVision