Quality Engineer of Design and Development (m/f/d)
On-site · Dresden, Saxony, Germany
Job Summary
Coordinate quality planning in product development and ensure adherence to the development process. Support development projects with quality-related tasks and conduct document and phase reviews, contributing to cross-functional quality management activities in design and development. Support product development teams in design input/output, design verification and validation, design changes, risk management, and design transfer activities. Contribute to development documentation and product risk analyses, and prepare, review, and approve verification and validation plans including software validation for active medical devices. Evaluate and qualify suppliers, contribute to quality assurance agreements, and plan, conduct, and document supplier audits with follow-up on actions. Collaborate with Purchasing, Pilot Production, and Supplier Quality Engineers/Managers across Heraeus Medevio sites. Requires a university degree, several years of experience in regulated industries, knowledge of ISO 9001/13485/FDA QMSR/ISO 14971, English proficiency, and a proactive, team-oriented mindset. Open to candidates with nontraditional backgrounds and a strong willingness to learn.
Required Qualifications
- university degree
- several years of experience in development or quality roles within regulated industries
- sound knowledge of ISO 9001, ISO 13485, FDA QMSR, ISO 14971
- Qualification as an internal auditor is an advantage
- experience in validation and qualification activities
- basic knowledge of regulatory requirements for medical devices
- very good English language skills
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