Quality Engineer of Design and Development (m/f/d)

Stellenbeschreibung:

Overview

In this role, you coordinate quality planning in product development and ensure adherence to development processes. You support cross-functional projects through quality tasks, reviews, and QMS activities across design and development. You contribute to design input/output, V&V, changes, risk management, and design transfer, while guiding supplier quality and audits. You’ll craft and review development docs and risk analyses, and assess verification outcomes. You drive supplier qualification and QA agreements to enable reliable product launches.

Verantwortungsbereiche

Coordinate quality planning in product development and ensure process adherence
Conduct quality-related tasks and reviews across development projects
Support design input/output, design verification and validation, risk management, and design transfer
Prepare, review, and approve verification/validation plans (including software) and evaluate results
Evaluate and qualify suppliers to meet development requirements
Develop and manage supplier quality agreements and conduct supplier audits with action follow-up
Assess supplier change notifications and monitor implemented actions
Collaborate with Purchasing, Pilot Production, and Supplier Quality teams across sites
Contribute to development documentation and product risk analyses

Zentrale Anforderungen

University degree
Several years of experience in development or quality roles within regulated industries (medical technology, automotive, aerospace, or pharmaceuticals)
Strong knowledge of quality management systems (ISO 9001, ISO 13485, FDA QMSR, ISO 14971)
Basic knowledge of regulatory requirements for medical devices (advantage)
Internal auditor qualification (advantage)
Experience in validation and qualification activities (desirable)
Very good English skills (written and spoken)
Team-oriented and solution-driven with strong communication skills
Willingness to learn and grow professionally