- 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, proposing corrective measures and monitoring progress.
- Actively participate in daily activities such as Material Review Board meetings, production escalations, supplier engagements, and team meetings.
- Lead and contribute to the enhancement of product and process performance through the application of Quality tools and techniques (CAPA, DMAIC, Statistical Process Control, 8D, etc.).
- Process, validate, and close Quality Notifications (QNs) in SAP, and manage Non-Conformity (NC) documentation for non-conforming products.
- Review and approve documentation before release, including Device History Record, Device Master Record, and Design History File.
- Bachelor's degree in a technical field.
- 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 quality tools such as Pareto analysis, risk analysis, Ishikawa diagrams, FMEA, 8D, statistical process control, 5S + 1, PPA or APQP, DMAIC.
- Strong process orientation with the ability to develop and optimize procedures and supporting documents.
- Excellent analytical, problem-solving, and root-cause analysis skills.
- Ability to effectively communicate and present issues to management.
- Proficient in Dutch and English communication and reporting.
- Characteristics: people-oriented, proactive, results-driven, resilient under pressure, and disciplined.
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Quality Engineer - Best, Nederland - Yacht
Beschrijving
FunctieomschrijvingQuality Engineer
Start Date: ASAP
Duration :1 year
Location:Best,Eindhoven
Join the Quality team for Philip's Factory Best and play a crucial role in ensuring product excellence and regulatory compliance. Reporting to the Q&R function with a dotted line to the Factory leader, you'll focus on maintaining high-quality standards while driving manufacturing excellence. Your mission is to deliver top-notch products with exceptional reliability, contributing to our journey towards becoming a world-class Operations organization.
Key Responsibilities:
Your Role in Factory Best:
Joining the Factory Best organization, a key operational site for Health Systems at Philips, you'll play a pivotal role in driving operational excellence. Our team manufactures, refurbishes, and repairs medical devices and components while ensuring safety, compliance, and effectiveness. Additionally, you'll be involved in preparing and implementing changes to products, components, and production processes, as well as managing manufacturing transfers from Industrialization Engineering.
Requirements:
Get in touch,if you have questions at