In this role, you have the opportunity to:
We are looking for a change leader to align quality practices developing medical device business to the Philips QA standards. The challenge is to integrate a fast growing business in a corporate structure, while enabling market launches and growth. For this, you will need excellent influencing skills, in-depth knowledge of relevant Quality Assurance practices, a working knowledge of the regulatory context and understanding of design controls.
You are the main interface between the QA team and development team. You facilitate meeting project goals in a compliant manner and you understand how quality policies and development processes interact. You work closely with Regulatory Affairs, Product Development, Clinical, Operations, Service, Supply Chain and Marketing & Sales.
The ideal candidate should have an understanding of product risk management and would be able to work at the engineering level with designers to develop product risks, helping with severity levels and occurrence rates. You will have to critique and agree that requirements are captured appropriately (as well as most other DHF items, inputs, outputs, V&V, transfer).
You are responsible for:
Mentor and coach a growing development team on compliance requirements.
Collaborate with other functions and departments on QA related aspects.
Ensure released products are developed, manufactured, distributed and serviced at the right quality levels, in compliance with relevant regulations and Philips policies.
Ensure Quality & Regulatory aspects are adequately covered in the selection, control and monitoring of suppliers.
Release of finished devices for clinical tests and delivery to customers.
Be an ‘ambassador’ for quality assurance and drive quality awareness and improvement.
Compliance, effectiveness and efficiency of the QMS and operations.
Contribute and support to track quality objectives
You are a part of:
This position will be part of a newly developing Quality team for Philips’ newest acquisition, Neuro. Philips Neuro is a medical device company that designs, develops and commercializes a range of non-invasive neurodiagnostic products used to monitor and interpret brain activity. A key component of these products is Neuro’s proprietary dense array electroencephalography (dEEG) platform technology. The dense array method gathers brain activity data from many more electrodes than conventional EEG products (up to 256), generating significantly higher quality and more precise levels of information. With regulatory clearance in the US, EU and a number of other major international regulatory bodies, the Company’s technology has been increasingly adopted as a powerful research tool and more recently as a cost effective and patient friendly clinical neurodiagnostic platform.
To succeed in this role, you should have the following skills and experience:
Experience with product development and design controls.
Background in a Regulated Industry, Medical Devices or IVD.
Experience utilizing quality related tools and techniques (Statistics, SPC, DOE, Capability Analysis, FMEA, Validation, etc.)
Experience with production and process controls.
Experience in supporting Notified Body and Regulatory Audits.
Knowledge of medical European and US standards and regulations
You are a hands-on contributor, leading by example, who takes ownership and drives QA topics in projects.
Proven track record as a change leader.
Strong communication and influencing skills.
Excellent verbal and written communication skills (English)
Bachelor’s degree with at least 8 years relevant experience in Quality Assurance.
In return, we offer you
A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.
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.
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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As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.