Role DescriptionAs mentioned you will become part of a dynamic and technology- driven business setting. Your aim is to improve the quality system in which you are supported by internal and external stakeholders. On a daily basis you will interact with suppliers to check on the maintenance and efficiency of the supplier QMS. Furthermore, you are involved with the development and improvement of quality standards for the organisation’s suppliers. You have a crucial role for the execution of supplier audits and will assist the entire procedure. In particular, you will identify points of improvement that are related to supplier quality system, and which are in line with Corporate, International and European documentation and legal principles. You are the point of contact when it comes down to questions about and/ or discrepancies within QMS.
ResponsibilitiesAs a Supplier Quality Engineer, you are responsible for the supplier Quality Management System in general. You will receive the responsibility to maintain, asses and improve the QMS, and keep on track of relevant changes and specifications applicable to the system. Furthermore, your role includes: • To be aware of the internal and external regulations including ISO qualifications. • To overview processes and applications conducted by your team which includes supplier containment, CAPA’s , Document control, and risk management • Constantly analyzing the supplier data and processes to trace risks and identify improvements. • Maintenance of relationships with both internal and external stakeholder • Keeping on track with the KPI’s of the supplier department • Maintenance of supplier lists on a local and international level • Taking the lead in the execution of internal and external audits • Ensuring compliancy for both Quality and Regulatory principles according to the FDA, IMB and notified bodies
Requirements• Bachelor in Engineering • Minimal 3 years of experience in the Medical Devices industry in a manufacturing environment • Minimal 6 years of experience in Quality Assurance within the Life Sciences industry • Excellent knowledge of GMP, ISO 13485, 21 CFR Part 820, 803, 806 and preferably knowledge of Asian standards and regulations • Evidence of experience in relationship building and maintenance of relations with authorities and other external stakeholders • Individual operator yet team player • Excellent analytical and problem-solving skills • Fluency in English and Dutch • Strong in communication skills
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Juliette van Kraaij.