Quality Engineer of Design and Development (mfd)

The following challenges await you:

• You coordinate quality planning in product development and ensure consistent adherence to the development process.
• You actively support development projects by performing quality-related tasks and conducting document and phase reviews while contributing to cross-functional quality management activities in design and development.
• You support product development teams including but not limited to design input/output design verification and validation design changes risk management and design transfer activities.
• You contribute to the creation review and approval of development documentation and product risk analyses for your assigned products.
• You prepare review and approve verification and validation plans including software validation for active medical devices and assess results and conclusions against development requirements.
• You evaluate and qualify suppliers regarding their suitability to meet development process requirements.
• You contribute to the development of quality assurance agreements with suppliers.
• You plan conduct and document supplier audits together with Quality Systems and ensure effective follow-up of agreed actions.
• You assess supplier change notifications and monitor the implementation of agreed measures.
• You collaborate closely with Purchasing Pilot Production and Supplier Quality Engineers / Supplier Quality Managers across Heraeus Medevio sites.

Your profile:

• You hold a successfully completed university degree.
• You have several years of experience in development or quality roles within regulated industries (e.g. medical technology automotive aerospace or pharmaceuticals).
• You possess sound knowledge of established quality management systems (e.g. ISO 9001 ISO 13485 FDA QMSR ISO 14971).
• Ideally you have basic knowledge of regulatory requirements for medical devices.
• Qualification as an internal auditor is an advantage.
• Experience in validation and qualification activities is desirable.
• You have very good English language skills both written and spoken.
• You are a team-oriented and solution-driven professional with strong communication skills.
• You demonstrate a continuous willingness to learn and a strong interest in professional development.