Quality Engineer

Job Title: Quality Engineer

Contract: Via Randstad Company

The candidate should be located in the Netherlands/Europe

Your Role: Join our dedicated Quality team at Factory Best, where you'll play a pivotal role in ensuring product quality, and regulatory compliance, and driving manufacturing excellence. Reporting to the Q&R function with a dotted line to the Factory Leader, you'll contribute to achieving timely releases of high-quality products with exceptional reliability.

Key Responsibilities:

• Ensure full quality and regulatory compliance for assigned unit(s) and Building Blocks.

• Adhere to company procedures and maintain compliance with FDA CFR regulations and ISO 13485:2016 standards.

• Conduct internal audits on relevant procedures, regulations, and instructions, propose corrective measures, and monitor progress.

• Proactively participate in daily direction of assigned unit(s), including MRB (Material Review Board) meetings, escalations (production stop), supplier meetings, and daily team meetings.

• Take charge and actively contribute to maintaining and improving product and process performance using Quality tools and techniques such as CAPA, DMAIC, Statistical Process Control, and 8D.

• Process, validate, and close Quality Notifications (QN) in SAP, and manage NC (Non-Conformity) documentation for non-conforming products.

• Review and approve documentation before release, including Device History Record, Device Master Record, and Design History File.

Your Team: Join the Factory Best organization, a key Operations site for Health Systems within Philips. Our team focuses on operational excellence, manufacturing, refurbishing, and repairing medical devices and components. Additionally, we are responsible for preparing and implementing changes to products, components, and production processes for released products, as well as managing manufacturing transfers from Industrialization Engineering.

Skills and Experience Required:

• Bachelor's degree in a technical field with a minimum of 4 years of experience in quality engineering within an operational environment, preferably in medical devices or pharmaceuticals.

• Demonstrated expertise in First Article Inspections and Incoming Goods Control.

• Proficiency in tools such as Pareto analysis, risk analysis, Ishikawa diagrams, FMEA, 8D, statistical process control, 5S + 1, PPA or APQP, and DMAIC.

• Process-oriented mindset with the ability to develop and optimize procedures and supporting documents.

• Ability to effectively communicate issues to management level.

• Good communication and reporting skills in Dutch and English (required)

If you find it interesting to pursue, apply before April 12, 2024, or email your resume to Pallavi.mahadik_1@philips.com.