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In this role, you have the opportunity to

Help build a high growth business that will help improve the lives of millions of people while advancing Philips journey as a global leader in Health Technology.

As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world. You will report directly to the SR QMS Manager.

Responsibilities

• Ensures compliant and effective QMS’s are maintained in scope; supports standardization of MS/QMS processes

• Key contributor to transformation of all current MS/QMS’s; revises processes, reviews and processes change requests

• Active Change Management and Impact Analysis/Change lead to ensure successful change management site engagement

• Ensures Document Control is established and ensures training profiles are assigned and enforced and training administration is established; back-up TSA support

• Ensures Q&R requirements are effective in all processes

• Quality Management System process expert, acting in support of the local business Heads of Q&R and QMS element owners across the business to deploy standardized Philips processes

• Support external and internal audit readiness and provides support during external and internal audits

• Actively participate in Quality & Regulatory initiatives as a cross functional contributor

• Maintains the QMS while driving QMS transformation locally in support of strategic initiatives including Philips Excellence Process Framework

• Demonstrate operational excellence and ensure quality in all deliverables

To succeed in this role, you should have the following skills and experience

• Bachelor’s degree in Engineering or equivalent plus a minimum of 5 years of related experience in the medical device or another highly regulated industry

• Expert understanding of appropriate global medical device regulations, requirements and standards, including FDA’s 21 CFR Parts 50, 54, 56, 803, 806, and 812, 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), EU MDR, Japanese MHLW Ordinance 169, ANVISA, ISO 14971, ISO 9001, ISO 14155, and ICH E6.

• Government/regulatory-body Quality System auditing/inspection experience preferred (i.e., former FDA)

• Excellent computer skills and the ability to transcribe inspection/audit proceedings in real time

• Project Management and process/organizational change management experience

• Demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts

• Solid organizational and interpersonal skills plus strong communication

• Ability to analyze information and come to conclusions based on presented data

• Open to other’s ideas and working collaboratively across functions and/or businesses

• Fluent in English and German

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there,you can also learn about our recruitment process , or find answers to some of the frequently asked questions .