Quality Engineer Design and Development

Contract Medical International GmbH HRdirekt; Dresden; On-site; EUR 60,000 - 90,000; Full time

Job summary

Heraeus Medevio is delivering lifesaving medical devices worldwide. This role focuses on coordinating quality planning across development, supporting QA tasks, and ensuring compliance with ISO 9001/13485 and ISO 14971.

You will collaborate with design, purchasing, and supplier quality teams to drive robust development and risk management for active medical devices. We seek a degree-holding professional with experience in regulated industries, strong English skills, and a proactive approach to

Qualifications

• Completed university degree.
• Several years of experience in development or quality roles within regulated industries (medical technology, automotive, aerospace, or pharmaceuticals).
• Sound knowledge of ISO 9001, ISO 13485, FDA QMSR, ISO 14971.

Responsibilities

• Coordinate quality planning in product development and ensure adherence to the development process.
• Support development projects by performing quality-related tasks and reviews, contributing to cross-functional quality management.
• Support product development teams with design input/output, design verification and validation, design changes, risk management, and design transfer.

Skills

Quality planning

Cross-functional collaboration

Quality management

Regulatory awareness

Auditing

Validation & qualification

Written & spoken English

Communication

Willingness to learn

Education

University degree

Job description

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]

https://mycareer.heraeus.com/job-invite/59344/