guide and support business groups, markets and enabling functions to always do the right thing. As a CAPA & Audit Manager International Markets within the PQMS markets central team, you will drive QMS (Quality Management Systems) compliance in the markets and associated functions. Office location is Eindhoven. We are open for people working from home.
You are responsible for
working closely together with the PQMS markets central team, the market Q&R teams and the function leaders in order to drive continuous improvement.
Key areas of responsibilities for this role include:
Supporting international markets CAPA & Audit program working with market functions and business clusters and functions for cross collaboration of CAPAs and/or QMS projects and continuous improvements of the Multi Market OneQMS
Defining and running improvement projects end to end together with market leadership in accordance with improvement tools DMAIC, PRIDE and Daily Management
Chairing EMEA CAPA Review Board (CRB) meetings and participating in the global CRB meetings
Identifying and resolving compliance risk through implementing corrective and preventive measures, use of root cause analysis tools and perform trending analysis in conjunction with various stakeholders
Performing internal audits of market organizations and supporting functions
Reviewing of responses to audit findings for completeness and effectiveness
Cultivating continuous improvement mindset and creating a platform to share best practices and training needs among different functions within international markets
You are a part of
The PQMS markets central team which plans, controls and manages relevant QMS activities for all 17 markets within Philips. The core business of the markets is the sales, marketing, distribution, installation and servicing of Philips medical and non-medical devices and solutions designed & manufactured by the Business Units: Personal Health, Precision Diagnosis, Image Guided Therapy and Connected Care.
The PQMS markets central team consist of 30 QMS professionals mainly based in Eindhoven, the Netherlands as well as other regions worldwide. You will be reporting to the Head of International Markets PQMS.
To succeed in this role, you should have the following skills and experience
You are excited by the unique professional challenges that our Quality Transformation presents, with strong technical competencies and resilience in often demanding situations. We are looking for a change manager - a driver and executor who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life for the billions of people our brand touches each year. Specific skill requirements for this role:
Strong CAPA Knowledge and experience is required
Medical devices or pharma experience is required
Preferably experienced Auditor with good knowledge of applicable regulations/standards (i.e. ISO 9001, ISO 13485, 21CFR820, MDD, MDR, MDSAP).
Experienced with Lean Manufacturing and Six Sigma. Preferably certified (theoretical and practical) Green- or Black Belt (preferred)
Knowledge of ISO 9001:2015, ISO 13485:2016, EU MDR, 21 CFR 820 and MDSAP
Strong inter-personal skills like stakeholder’s and change management techniques
Able to proactively and independently resolve issues
Highly proficient in spoken and written English
In return, we offer you
We welcome you to a challenging, innovative environment with great opportunities for you to explore.
Our benefits are very competitive and designed around your preferences:
A market conform salary
25 Days of leave and the possibility to purchase up to 20 extra days off annually
A variable bonus based on both Philips results and personal performance
Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
Solid company pension scheme and attractive collective health insurance package
Opportunity to buy Philips shares and products with discount
Healthy work-life balance
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. 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 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.
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