Quality Systems Engineer

Job description

Job Title Quality Systems Engineer Job Description: Quality Systems Engineer Support business and site level aspects of the quality management system for the Philips Image Guided Therapy Devices business. You will support sites within this business in continuous maintenance and improvement of the Quality Management System and its subsystems. Your role: •Support initiatives to drive simplification and integration of quality system requirements and business processes to ensure compliance and facilitate global business growth. - Supporting and maintain Quality Management Systems to meet FDA 21CFR820 (QMSR), ISO13485, MDSAP, and other regulatory requirements as applicable for the site. Systems include (but not limited to): Change Management; Document and Record Control; CAPA; Audits; Training; Data Analytics and Trending; Management Review. - Support the respective QMS architecture and processes. - Support and sometimes execute change notices within the Document Controls system (Windchill) ensuring appropriateness and effectiveness. - Escalate areas of non-compliance, risk and/or potential improvement to Management and develop plans for appropriate action to address causes of deficienc...