Quality Engineer-Team Lead

Job Title: Quality Engineer

Contract: Via Randstad Company

The candidate should be located in the Netherlands/Europe

Your Team: You will be part of the dedicated Quality team for the Factory Best. The Quality department of the factory Best will be reporting to the Q&R function and will have a dotted line to the Factory leader. The Quality department focuses 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.

Your Role: You will be collaborating with a team of Quality Engineers and Reject Handlers. As a Team Lead, you will be responsible for the coordination and functional control of the Quality Engineering team. Within Factory Best we build different modalities like magnetic resonance systems and image–guided therapy systems (IGT). You will be the single point of contact for such a modality for customers like legal manufacturers and operations managers. You will help the team by also participating in the different processes that we are using.

You are responsible for:

• Daily operational and functional control of your team. Lean principles like daily management will be used. Coaching and motivating team members to achieve excellent results. Providing performance input from your team members to the hierarchical manager.

• Ensuring full quality and regulatory compliance for the involved unit(s) and Building Blocks. Adhering to company procedures and maintaining compliance with FDA CFR regulations and ISO 13485:2016 standards.

• Performing internal audits on applicable procedures, regulations, and instructions, proposing corrective measures for the audit findings, and following progress. Proactively participating in teams like MRB (Material Review Board), escalations (Factory Hold), supplier meetings, and daily team meetings.

• Taking charge and participating in maintaining and improving the 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).

To succeed in this role:

• At least Bachelor level with a technical background. with at least 4 years’ experience in quality engineering within an operational environment (preferably medical devices, pharma, automotive or aerospace) is required.

• Experience with Medical Device Regulations and standards (FDA CFR,ISO 13485:2016)

• Some team management / coordinating experience. Continuous improvement mindset.

• Process-minded and able to make and optimize procedures and supporting documents.

• Excellent analytical, problem-solving and root-cause analysis skills, 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.

• Ability to present issues to a management level. Both Analytical and conceptual combined with strong leadership on an operational level. Be capable of driving change with a sense of urgency and bias for action. • 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.

If you find this role interesting, kindly apply online before March 25, 2024. Thank you.