Quality Engineer

Role: Quality Engineer

Contract: Via Randstad

Way of working: 5 days onsite

As a Quality Engineer, you are the guardian of product excellence. You will safeguard quality by identifying risks, resolving complex defects, and driving process improvements to ensure manufacturing reliability and efficiency in a high-tech, low-volume environment.

Your responsibilities:

• Manage Non-Conformances (NC) and Quality Notifications (QN). Lead root cause analysis (8D, 5 Whys) and drive CAPAs to closure.

• Partner with operators and engineers to decide on product disposition (rework, scrap, or use as-is) and keep production moving.

• Monitor quality trends (DPU) to reduce rework and increase "first-time-right" yields.

• Support New Product Introductions and transfers; coordinate with R&D, Suppliers, and Manufacturing Engineering to resolve systemic issues.

• Ensure all processes and documentation align with strict medical quality standards.

Background and experience required to perform this role:

• BSc/MSc in Engineering (Industrial, Biomedical, Mechatronics, or similar) with 0-2 years in a high-tech manufacturing or engineering environment.

• Familiarity with ISO 9001/13485/16949, FMEA, and SPC.

• Fact-driven and structured problem-solving (e.g., DMAIC, 8D).

• Experience with SAP (MES) or Windchill is a plus; Six Sigma Green Belt preferred.

• A hands-on, detail-oriented approach with a strong sense of urgency. You take end-to-end ownership of issues from signal to solution.

• Ability to influence and challenge stakeholders across all levels, from shopfloor operators to management.

• Fluent in English (Dutch is a plus).