Role DescriptionFor this position we're looking for a professional Quality & Regulatory specialist, experienced in internal and external audits in the Medical Devices industry.
ResponsibilitiesYou are responsible for • establishing and maintaining the internal audit program for all activities in scope of the IGT-S QMS • end-2-end planning and managing of all external audits/inspections (e.g. by Notified Bodies; initial and surveillance audits) for the IGT-S • managing the follow-up of audit results, including communication and sharing of relevant audit information across other Philips entities. • governing the full CAPA process ensuring CAPAs are successfully managed and tracked until closure • ensure proper alignment of the audit and CAPA process with any corporate PQMS and/or E2E process change initiatives • interfacing with process owners and business representatives on planning and managing process audits within the IGT-S as well as the business units
Requirements- Experience in the Medical Devices industry - Experience in performing both internal and external audits and CAPA - Strong knowledge of Quality Management Systems - Good communication skills - Fluent in English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ria Bos.