Expires soon Philips

Quality System Engineer

  • Eindhoven (Eindhoven)
  • Design / Civil engineering / Industrial engineering

Job description

Your Challenge

Within the global consumer products business managing the QMS compliance in the US and Canada and providing recommendations to management and functional business units. Business sells Health Canada and FDA Class I and Class II products. Firm command of FDA regulations and CMDR a must. CPSC and CPSIA knowledge and experience a plus. A major focus of this position will be working within a global network to communicate and address QMS challenges applicable to the US, Canada and EU.

Responsibilities

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 PQMS 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 Leads/participates in the maintenance of the quality documents until such time as they are determined to be no longer applicable as part of the PQMS transition.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 CAPA documents and matrices for tracking trending and reporting. Ensures the addition and management of any local QMS documents in line with the evolution of the CAPA.

Your Team

You will report to the Quality System Manager- Eindhoven team is made up of 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.

Our Offer

Philips Personal Health business offers rich, new consumer experiences that meet consumers’ desire for wellness and pleasure throughout each part of their day and during key milestones throughout their life. We are a highly entrepreneurial organization, passionate about developing innovations that meet consumer’s personal health & well-being needs in a unique way, relative to their Mind, Body, and Appearance. The Personal Health Group is one of three market-driven sectors within Royal Philips Electronics that delivers lifestyle solutions aimed at improving the lives of 3 billion people a year by 2025. Named one of the Top 50 Happiest Companies in America, Philips provides a unique opportunity for each employee to create their legacy in life through their work in a way that is personally meaningful to them.

We Are Looking For

·  Bachelor’s degree in a scientific or technical field
·  3+ years of experience in the medical device industry
·  Working knowledge of GMP’s and other FDA regulations
·  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.
·  Strong IT skills, including MS Word (advanced user), Excel, Visio, and related MS Office applications.
·  Proven analytical capabilities
·  Excellent communication, organizational and project management skills
·  Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.

Contact

In case of technical difficulties with your job application, such as login issues or a need to reset your password, please send  an email to 
(Note: To ensure fairness and legal compliance in our recruitment processes, only technical issues will be monitored through the above inbox. Please do not submit resumes or applications to this email, as they will not be reviewed. Only applications received through the online application process will be considered.)

Make every future a success.
  • Job directory
  • Business directory