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Philips Audit & CAPA Manager in Best, Netherlands

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In this role, you have the opportunity to be part of

the dedicated Quality team for the Image Guided Therapy (IGT) systems in Best. This position is part of Q&R team and will be reporting into the Head of Q&R IGT Systems. The Q&R team focusses on ensuring product quality, while maintaining full compliancy and driving manufacturing excellence. The aim is to achieve timely releases of products with high quality and outstanding reliability. This position plays important role to keep driving continuous improvements on Product quality and compliance through effective audit and CAPA processes.

By joining this organization, you will be part of the transformation journey towards a world class Operations organization to better serve our customers with speed and excellence.

You will manage 3 people (CAPA Manager, Audit Manager, Administrative employee).

As a CAPA/Audit manager you have the opportunity to be at the heart of managing the Audit and CAPA process across IGT System Business Group of Best sit. You will be managing all internal/external audits of the Quality Management System to ensure its continued compliance to laws and standards. You will also define and coordinate projects to effectively share the results of CAPA resolution and audits and use these as drivers for continuous improvement (program management). You will be the spider in the web interacting with process representatives throughout the Philips organization on audit & CAPA related topics. You will be driving Key Performance Indicators related to Audit and CAPA and reporting to management on regular basis.

You are responsible for

  • establishing and maintaining the internal audit program for all activities in scope of the QMS

  • end-2-end planning and managing of all external audits/inspections (e.g. by Notified Bodies; initial and surveillance audits, US FDA inspection)

  • managing the follow-up of audit results, including communication and sharing of relevant audit information across other Philips entities.

  • governing the full CAPA process ensuring CAPAs are successfully managed and tracked until closure

  • ensure proper alignment of the audit and CAPA process with any corporate PQMS and/or E2E process change initiatives

  • interfacing with process owners and business representatives on planning and managing process audits within the business.

  • Ensuring that pool of auditors are properly trained on changes in the regulation and their skills are maintained to effectively conduct internal audits to latest standards.

In this role, you have the opportunity to be part of

the IGT Systems Business in Best, which is one of the main business of IGT Cluster within Philips. Our business is marketing interventional x-ray medical devices and one of the key focus area within Philips which is growing.

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

  • At least a bachelor degree (preferably in a technical discipline) is required in combination with at least 5-8 years of auditing experience in the medical device industry (required)

  • Auditing experience is a must, CAPA is a strong preference

  • Current and valid certification with a recognized Accreditation body in Quality Process Auditing as a recognized Lead Auditor is required

  • Experience with ISO-13485 and common world-wide med dev regulations (FDA, MDD) is a must

  • Experience with commonly used problem solving methodologies

  • A detail-oriented and analytical attitude who can work both independently and in a team

  • A good communicator on different organizational levels in English

  • Strongly preferred: proven experience in multi-site, multi-disciplinary quality organizations

  • Character: people-oriented, no-nonsense, pro-active, make-it-happen mentality, pressure-resistant, able to get things done from people, disciplined

In return, we offer you

An exciting role in our professional Quality & Regulatory organization. Philips will offer a path towards your most rewarding career, with opportunities to show your skills and develop yourself in many ways.

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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html

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