In this role, you have the opportunity to Increase and ensure the compliance level, concerning Quality System relevant Software Validation with the Philips Market organization. As Software Engineer you will part of a Philips Quality Management System team of 25 people and support the Market Quality & Regulatory organizations within Philips
You are responsible for
•Execute and /or manage SW validation & control activities
•Ensure that new software and changes to existing software or infrastructures are validated before approval and use
•Ensure the accuracy, completeness and compliance of SW validation deliverables by reviewing the SW validation packages of SW applications which automate Quality System processes
•Authors, reviews and/or approves SW validation deliverables for non-product SW, including but not limited to SW validation plans, requirements, test plans/protocols/results, risk assessments, traceability matrix and summary reports
•Support management and standardization of QMS processes in scope to ensure effective and compliant QMS. Drive deployment of Non Product System Software Validation process in the local Quality Management System, ensuring local and cross business harmonization, standardization and regulatory compliance
•Manage and improve compliance to ISO 13485, EU MDR and FDA regulations, other Regulatory Agencies as required
•Business process expert for processes in scope, acting in support of the local Market organizations and the PQMS leader and QMS element owners across the markets to deploy harmonized and standardized Philips processes
•Establish and ensure adherence to schedules, work plans
To succeed in this role, you should have the following skills and experience
•Bachelor’s degree plus at least 2 years of related experience in the medical device, automotive, aerospace, pharma or Defense.
•Experienced with IT software applications development and SDLC (Software Development Life Cycle) methodologies from requirements to validation.
•Expertise in validation of enterprise wide quality IT systems using established Computer System Validation (CSV) methodology such as GAMP 5 and FDA guidelines
•Strong background in FDA, ISO and EU regulations for medical devices and healthcare; especially FDA 21CFR Part 820/Part 11, ISO 13485 and EU Annex 1 (highly preferred)
•Proven experience in Quality Management System processes, including cross sector or business process standardization, ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations
•An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization
•Project Management (development of project plans, status meetings, project reporting, etc.) and organizational change management;
•Communication in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor
•Manage time working on multiple projects simultaneously
You are a part of
The PQMS Markets Central Team plans, controls and manages relevant QMS activities for all 17 Markets worldwide within Philips. This includes Personal Health, Sleep and Respiratory Care, Diagnosis and Treatment, and Connected Care and Health Informatics and Customer Services. The core business of the Markets is Sales, Marketing, Distribution, Installation and Servicing of Philips medical and non-medical devices and solutions designed & manufactured by the Business Units.
The PQMS Markets Central team consist of 25 QMS professionals mainly based in Eindhoven, the Netherlands.