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

Heraeus; Dresden; Sur place; EUR 70 000 - 90 000; Plein temps

Avantages offerts par ce poste

Health benefits

Résumé du poste

Heraeus Medevio seeks a Quality Engineer of Design and Development to coordinate quality planning in product development and support cross-functional teams in quality activities. You will review development documentation, manage risk analyses, and ensure adherence to quality standards for medical devices.

The role requires a university degree and several years of experience in regulated industries, with strong knowledge of QMS such as ISO 13485.

Qualifications

• A completed university degree.
• Several years of experience in development or quality roles within regulated industries.
• Sound knowledge of quality management systems (e.g., ISO 9001, ISO 13485, FDA QMSR, ISO 14971).
• Knowledge of regulatory requirements for medical devices is a plus.
• Internal auditor qualification is advantageous.
• Experience in validation and qualification activities is desirable.
• Very good English language skills, both written and spoken.
• Team-oriented, solution-driven with strong communication skills.
• Willingness to learn and pursue professional development.

Responsabilités

• Coordinate quality planning in product development and ensure adherence to the development process.
• Support development projects by performing quality tasks and conducting reviews, while contributing to cross-functional quality activities.
• Support product development teams in design input/output, verification/validation, changes, risk management, and design transfer.
• Create, review, and approve development documentation and risk analyses for assigned products.
• Prepare, review, and approve verification and validation plans, including software validation for active medical devices, and assess results.
• Evaluate and qualify suppliers to meet development process requirements and develop quality assurance agreements.
• Plan and conduct supplier audits with Quality Systems and ensure follow-up of actions.
• Assess supplier change notifications and monitor implementation of measures.
• Collaborate with Purchasing, Pilot Production, and Supplier Quality Engineers across Heraeus Medevio sites.

Connaissances

Quality engineering

Regulatory knowledge

Teamwork

Communication skills

English proficiency

Formation

University degree

Description du poste

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

Date: Sep 16, 2026

Company: Heraeus

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

Permanent

About Heraeus

Making displays foldable? Helping hearts beat with medical innovations? Or breathing new life into precious metals? As a family-owned global technology group we help our customers to always being one step ahead.

About Heraeus Medevio

Together we improve lives. At Heraeus Medevio, we bring lifesaving and life-changing medical devices to market through partnerships with medical device manufacturing companies. Backed by Heraeus Group, we are committed to the growth of our teams and organization by providing an open space for open minds.

To reach our vision of improving 100 million lives every year, we foster a culture of curiosity that thrives on challenge, continuous learning, growth, and the opportunity to try new things. With sites in the United States, European Union, and Asia, and over 2,200 employees worldwide, together, we will meet tomorrow's challenges today.

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.