Quality System BPE
Project: PQMS Procedures & E2E Program
Part of the End 2 End program, the Quality System Business Process Expert supports the development, deployment and maintenance of the Quality Management System within Philips Healthcare, ensuring Philips cross sector harmonization, standardization and regulatory compliance.
You will ensure process compliance to regulations, and that optimization and efficiency are built into the Business Management and Quality Management System processes across all sectors and groups in partnership with the other business functions.
Location: Eindhoven, Netherlands with potential travel to Amsterdam, Netherlands
Provide compliance and Quality Management System process improvement support to the E2E Program teams to ensure compliance with optimization and efficiency in E2E processes.
Your main responsibilities are:
• Quality Management System Business Process Expert, acting in support of the Philips Healthcare Quality Assurance team and Q&R Business Process Owner, across the Philips Q&R network for the E2E program
• Participate directly as the Philips Healthcare Quality Management System Business Process Expert in Philips “Process Capabilities” deployment programs, in the Idea to Market (I2M), Market to Order (M2O), and/or Order to Cash (O2C) arenas. Ensuring compliance, efficiency and effectiveness of the processes within the Philips Healthcare sector, cross sectors, and at Philips corporate.
• This entails a thorough knowledge, as example, of Design (I2M), Marketing & Brand & Promotions (M2O), Production & Servicing (O2C) and Procurement /Purchasing
• Includes, but is not limited to all Idea to Market (I2M), Market to Order (M2O), and/or Order to Cash (O2C) processes.
• Support cross-Philips setup and deployment of the Quality Management Systems along business model lines as identified by End-to-End teams through the creation of Quality Transition Plan(s) that identifies appropriate Q&R activities to ensure compliance.
• Work with Philips End to End & ARIS process modeling teams, Business Management System and Quality Management System owners, as well as any other stakeholders to ensure new process descriptions and procedures (PDDs – Process Definition Documents) are efficient, effective, and compliant to the applicable regulations
• Work with Philips Software validation teams to ensure fully integrated, validated and compliant Philips Integrated Landscape (PIL) software application are deployed.
• Quality Assurance is an integral aspect of the global healthcare business including device design, development, manufacture, distribution, worldwide device marketing, sales, service, and post-market surveillance. This position is intimately involved in the process of ensuring Quality System Regulations are embedded within business processes and supports the harmonization of identified key processes by which the company and its sectors operate
We are looking for
• Bachelor’s degree or equivalent preferably in a scientific discipline
• Minimum of 7 years of experience working in Quality Assurance / Quality Engineering / Quality Systems supporting multiple functional disciplines within a global medical (device/Pharma) industry.
• Proven experience in Quality Management System processes, including cross sector or business process standardization (desired), ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations.
• A comprehensive understanding of the diverse worldwide medical device quality regulations, including areas of device design, development, manufacture, distribution, worldwide device marketing, sales, service, and post-market surveillance.
o This position requires an extensive knowledge of FDA QSR’s, ISO 13485, JPAL, China GMP’s and other worldwide Quality System Regulations.
• An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization
• Experience with deployment of Quality Management System processes as identified
o Demonstrated practical knowledge in the selected domain (I2M, M2O, O2C, Enabling)
• Skill set required for the department to operate:
o Project management experience, desired
o Good communication skills written & verbal in English
o Software validation experience: understanding of high-level view of the requirements and supporting processes.
o Demonstrated experience in collaborative working environments
o Experience addressing conflicts, escalation at team level to achieve desired results.
o Demonstrated experience handling deadlines, able to focus on targets
o Demonstrated experience-driving progress, taking initiative to achieve results.
o Experience understanding the process approach ‘End-to-End’, where, the optimization of customer value chain starts from ‘customer insight’ all the way to delivering products & service to the customers.