Philips Quality Systems Engineer in Eindhoven, Netherlands

Define and maintain the Quality Management System procedures to ensure compliance to Philips Policies, ISO 9001, ISO 13485, 21 CFR 803, 806 and 820, Canadian Food, Drugs, and Medical Devices Regulations (CMDR)and EU Medical Device Regulations.

Maintains, enforces, and manages a compliant and effective QMS for the activities in scope, as well as for effective and lean QMS structures and documents for Q&R processes at all levels.

Manage Remediation activities associated to improve site compliance Manage PQMS/PEPF related deployments and implementations.

Ensures proper audit planning and schedule meets the requirements of internal policies and external regulations.

Establishes and executes a transition plan for all QMS related activities in scope while maintaining compliance and effectiveness throughout the duration of the transition to the PQMS. Leads/participates in the maintenance of the quality documents until such time as they are determined to be no longer applicable as part of the PQMS transition.

Ensures the addition and management of any local QMS documents in line with the evolution of the PQMS.

Ensures training and training registration as per the QMS and generates training content for local QMS documents as necessary.

Maintains, enforces, and manages a compliant and effective CAPA Process for the activities in scope, as well as for effective and lean structures and documents for Q&R processes at all levels including CAPA compliance to regulations and standards ensured through proactive support and facilitation of the CAPA activities with individual CAPA owners Managing site CAPA program and leading CAPA Review Board meetings. Establishes the Philips CAPA Management System and manages its deployment including IQ-OQ-PQ Validation for web-based designed tool for the CAPA system.

Work on validation test protocols, conversion/migration of data, mapped configuration requirements mapped to corresponding regulation requirements as applicable for 21 CFR Part 11 and 820 Ensures proper CAPA planning and schedule meets the requirements of internal policies and external regulations.

Leads/participates in the maintenance of the Product/QMS documents and matrices for tracking trending and reporting. Ensures the addition and management of any local QMS documents.

In this role, you have the opportunity to

Operate within a global network to communicate and address a broad variety of QMS challenges applicable to the US, Canada and EU.

You are responsible for

  • Defining and maintaining the Quality Management System procedures to ensure compliance to Philips Policies, ISO 9001, ISO 13485, 21 CFR 803, 806 and 820, Canadian Food, Drugs, and Medical Devices Regulations (CMDR)and EU Medical Device Regulations

  • Maintaining, enforcing, and managing a compliant and effective QMS for the activities in scope, as well as for effective and lean QMS structures and documents for Q&R processes at all levels.

  • Managing Remediation activities associated to improve site compliance, aswell as PQMS/PEPF related deployments and implementations.

  • Ensuring proper audit planning and schedule meets the requirements of internal policies and external regulations.

  • Establishing and executing a transition plan for all QMS related activities in scope while maintaining compliance and effectiveness throughout the duration of the transition to the PQMS.

  • Leading/participating in the maintenance of the quality documents until such time as they are determined to be no longer applicable as part of the PQMS transition.

  • Ensuring training and training registration as per the QMS and generates training content for local QMS documents as necessary.

  • Maintaining, enforcing, and managing a compliant and effective CAPA Process, system and documentation for the activities in scope, as well as for effective and lean structures and documents for Q&R processes at all levels including CAPA compliance to regulations and standards ensured through proactive support and facilitation of the CAPA activities with individual CAPA owners; work on validation test protocols, conversion/migration of data, mapped configuration requirements mapped to corresponding regulation requirements as applicable for 21 CFR Part 11 and 820

You are a part of

The Eindhoven team is a highly talented and multi-national workforce that is approximately of 25,000 strong, and spans over 50 countries with sales in more than 100 countries. We are proud to claim market leadership positions for cutting edge solutions in the business areas of Personal Care, Oral Care, Shaving and Grooming, Mother & Child Care, and Coffee. Philips is home to popular brands such as Sonicare, AirFloss, Norelco, Avent, and Saeco.

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

  • Bachelor’s degree in a scientific or technical field

  • 5+ years of experience in the medical device industry

  • Working knowledge of GMP’s and other FDA regulations

  • Experience in FDA Remediation projects

  • Experience validating application activities.

  • Solid Analytical skills - demonstrated ability to trouble-shoot complex process/system issues.

  • Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.

  • Successful experience working with cross functional teams across multiple work locations

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 an extensive set of tools to drive your career, such as a personal development budget, free training and coaching.

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 .