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 compliance 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.
In this role, you have the opportunity to be part of the team of Quality engineers
You are responsible for
- 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).
You are a part of
In this role, you have the opportunity to be part of the Factory Best organization, which is one of the main Operation sites for Health Systems within Philips. Our Factory Best organization is driving operational excellence and manufactures, refurbishes and repairs our medical devices & components in a safe, compliant, and effective manner. Next to this, the Factory Best team is responsible for the preparation and introduction of changes on products/components/production processes for released products and receiving and implementing manufacturing transfers from Industrialization engineering.
To succeed in this role, you should have the following skills and experience
- 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.