SRQ119792 - Quality Management System Business Process Expert (RM Carla)

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Quality Management System Business Process Expert

• 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.
• 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  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.

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.


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