QA Manager

Company: Michael Page International Netherlands SA
Job type: Full-time

Manage, maintain and improve the OrbusNeich Quality Management System, provide QA/QC production support and support of new product development projects and launch of new products. Client Details OrbusNeich is a global pioneer in the development of life-changing vascular solutions. They offer an extensive portfolio of products that set industry benchmarks for vascular intervention. Their proprietary EPC Capturing Technology is featured on the world's first and only dual therapy stent, COMBO™. This industry-leading stent is designed to repair vessel injury and regenerate endothelium fostering natural vessel healing. In the Netherlands, they have an office in Hoevelaken with 50 dedicated employees. Description Management representative at OrbusNeich Medical Responsible for setting and communicating quality objectives Manage, maintain and improve the Quality Management System Conduct Management Reviews and CAPA meetings Responsible for day to day managing of the QA department Responsible for QA/QC activities, including but not limited to the below: Final release of products Internal quality system audits Supplier approval and monitoring, including supplier audits CAPA system Complaint handling Receiving, in-process and final inspections Process monitoring Environmental and cleanroom monitoring Sterilization validations Document control Training Support multi-site (China, NL, US) new product development projects and launch of new products. Responsible for realizing and ensuring design and development activities, including but not limited to the below: Design control Risk Management Product Quality Plans Process validations Design Transfer Post Market Surveillance Technical documentation and Design Dossiers Identify and interpret new or revised regulatory requirements for Medical Devices. Lead and participate in activities to implement changes to the OrbusNeich Quality Management System and products. Coordinate and manage audits and regulatory activities with respective agencies ( Notified Body, Competent Authorities etc.) Profile Level of education HBO-level (Technical/Operational, US BS degree or equivalent) Five years Quality Assurance experience in the Medical Device or Pharmaceutical Industry Fluently in English (verbal and written) Proficiency with MS-Office Supervisory experience Project management experience (Able to manage projects in detail, while meeting the deadlines and milestones) Able to build relationships across work groups and organizations; recognizes diverse stakeholder needs and gains support for shared organizational goals Resilient to Stress; keeps a realistic, but optimistic outlook for the future when faced by adversity; accepts the consequences of difficult decisions; learns from mistakes Job Offer Grow within the role and even within the (international) organization Salaryrange € ,- up to € ,-

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