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

RxREVU, Inc.; Dresden; Vor Ort; EUR 60.000 - 85.000; Vollzeit

Zusammenfassung

Heraeus Medevio is seeking a Quality Engineer of Design and Development to coordinate quality planning in product development, perform quality-related tasks, and support cross-functional teams across the development lifecycle. The role includes handling design verification/validation, risk management, and supplier qualifications to ensure compliant medical devices.

The ideal candidate holds a university degree with several years in regulated industries, strong knowledge of QMS standards (ISO

Qualifikationen

• Completed university degree.
• Several years of development or quality experience in regulated industries.
• Sound knowledge of quality management systems (ISO 9001, ISO 13485, FDA QMSR, ISO 14971).
• Ideally, basic knowledge of regulatory requirements for medical devices.
• Auditor qualification is an advantage.
• Experience in validation and qualification activities is desirable.
• Very good English skills, written and spoken.
• Team-oriented and solution-driven with strong communication.

Aufgaben

• Coordinate quality planning in product development and ensure adherence to the development process.
• Support development projects by performing quality-related tasks and document/phase reviews.
• Support product development teams (design input/output, V&V, design changes, risk management, transfer).
• Contribute to development of development documentation and product risk analyses.
• Plan, conduct, and document supplier audits with Quality Systems and follow up actions.
• Collaborate with Purchasing, Pilot Production, and Supplier Quality Engineers across Heraeus Medevio sites.

Kenntnisse

Quality mindset

Teamwork

Communication

Willingness to learn

English proficiency

Ausbildung

University degree

Tools

ISO 9001

ISO 13485

FDA QMSR

ISO 14971

Jobbeschreibung

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.

Any further questions?

Our Recruiting Team, Heraeus Medevio, is happy to assist you by email: [e-mail]. Or visit us at jobs.heraeus.com.