Quality & Safety
Secondment via YER
High Tech, Medical & Health, Aviation
Over deze vacature
In this role, you have the opportunity to be part of the dedicated Quality team for the Factory Best. The Quality department of the factory Best will be reporting into the Q&R function and will have a dotted line to the Factory leader. The Quality department focusses on ensuring product quality, while maintaining full compliancy and driving manufacturing excellence. The aim is to achieve timely releases of products with high quality and outstanding reliability.
By joining this organization, you will be part of the transformation journey towards a world class Operations organization to better serve our customers with speed and excellence.
• Ensuring full quality and regulatory compliance for his/ her unit(s) and Building Blocks,
• Adhering to company procedures and maintain compliance with FDA CFR regulations and ISO 13485:2016 standards,
• Performing internal audits on applicable procedures, regulations and instructions, proposes corrective measures for the audit findings and follows progress,
• Proactively participating in daily direction of his/ her unit(s) like MRB (Material Review Board), escalations (production stop), supplier meetings, daily team meetings,
• Taking charge and participate in maintaining and improving performance of products and processes via Quality tools and techniques (CAPA, DMAIC, Statistical Process Control, 8D,…),
• Processing, validating and closing QN’s (Quality Notifications) in SAP and particular NC (Non Conformity) documentation for non-conforming products,
• Reviewing and approving documentation before release (Device History Record, Device Master Record, Design History File).
With a growing presence in cardiology, oncology, and women's health, Philips operates in the areas of Imaging Systems, Patient Care & Clinical Informatics, Home Healthcare and Customer Services. Philips combines its clinical expertise and human insights to create innovative solutions across the continuum of care, in partnership with clinicians and our customers, to provide better value and expand access to care for millions. Our teams are working hard every day to improve patient outcomes all the way from disease prevention and screening to diagnosis, treatment, therapy monitoring, and disease management. Irrespective of whether the care cycle takes the patient from doctor's office to hospital or hospital to home, or simply from one medical department to another, Philips Healthcare's unique medical solutions are designed to optimize the quality and flow of patient information and clinical decision making.
Good working conditions
• Bachelor level (technical background),
• At least 4 years’ experience within quality engineering within an operational environment (preferably medical devices, pharma),
• Demonstrable experience with First Article Inspections and Incoming goods control,
• Knowledge of tools e.g. pareto, risk analysis, 5W/ 2H, Ishikawa, FMEA, 8D, problem solving methods, statistical process control, 5S + 1, PPA or APQP, DMAIC,
• Process minded and able to make and optimize procedures and supporting documents,
• Excellent analytical, problem solving and root-cause analysis skills
• Ability to present issues to a management level,
• Good communication and reporting skills in Dutch and English (required)
• Character: people-oriented, no-nonsense, pro-active, make-it-happen mentality, pressure-resistant, able to get things done from people, disciplined.