In this role, you have the opportunity to
Conduct quality assurance activities to ensure that all our products, materials, components in our distribution center maintained as per regulatory requirements and that quality management system is followed and maintained properly. Further, maintain complaint handling, medical device reporting, product recalls and post market surveillance and vigilance to ensure compliance with regulatory agencies.
You are responsible for
In conjunction with the Quality, Operations Management and Regulatory, ensure that all VE departments are compliant with all internal quality requirements.
Update and where necessary write SOPs to ensure that the company is compliant with quality guidelines.
Implementation of the IGT- Devices Quality System according to the European and International guidelines, which maintains our EN/ISO and other global regulatory requirements and links into our corporate quality manual and corporate SOPs.
Responsible for the document managing control (change order process).
Maintains all quality documents and records in an up to date manner.
Maintains the CAP – Electronic Training Management System (administrator EMEAI)
Assist the QA/RA Manager in the quarterly VE Management Review Meetings to review status of quality adherence in the company and to identify potential areas for improvement.
Ensure that all processes and records are in full compliance with implemented procedures by reporting on the performance of the quality system and creating the basis for improvements.
Carry out CAPA’s where necessary.
Carry out NCR’s where necessary.
Train all staff members on relevant areas of quality to their function as outlined in the training requirements.
Support to the Operations Team with the implementation of Physical Distribution, Logistics Operations and Field Services procedures.
Provide KPI’s to RA/QA Manager on regular bases.
Maintain the vigilance system (complaint reporting) in conjunction with the Global complaints organization, product return (RMA).
Support inspections and internal/external audits as required; coordinating all such activities with the corporate Management Representative or alternate Management Representative.
Keep abreast of applicable laws of the European Union and National Laws of the Member States of the EEA and International laws (with exception of Japan, USA and Canada) as it pertains to Post Marketing Surveillance.
You are part of
The Quality & Regulatory department for the Philips IGT devices International based in Zaventhem, Belgium. This team consists of 5 people: 2 regulatory specialists, 2 quality specialists and the Quality & Regulatory manager.
To succeed in this role, you should have the following skills and experience
Bachelor or Master of Science
3+ years of experience in the field of expertise Quality or Regulatory in the medical device industry (preferred) or pharma industry.
Profound knowledge regarding applicable quality system regulations and standards such as Medical Device Regulations and associated standards like ISO13485, ISO 14971 and EU standard (nice-to-have)
Experience as (internal) lead auditor, Lead Auditor Certification
Team player, strong communication skills, able to take initiative and work independently
Excellent proficiency of English language
In return, we offer you
A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this market-based 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.
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 .