Quality Engineer Medical Devices (m/f/d)

Quality Engineer Medical Devices (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:

• As a Quality Engineer at Medevio you strongly support all projects at our development center in Dresden.
• You support our product and process development teams, to ensure that test method, equipment, process, and software qualifications align with global and site procedures, regulations, and industry standards.
• In your role you collaborate with cross-functional teams to resolve internal and supplier non-conformities effectively, ensure smooth execution of projects and drive improvements.
• You support and conduct risk assessments and failure mode and effects analysis to ensure compliance and safety of our products throughout the product life cycle.
• It is your passion to analyze and interpret data to provide insights and recommendations for quality improvement initiatives.

Your profile:

• You have a relevant degree, or equivalent experience, in engineering, life sciences, or a related field.
• You come with minimum 5 years of experience in the field of process, software and test method qualification in controlled industries such as medical technology, automotive industry, aerospace, pharmaceutical industry.
• You possess strong knowledge of quality management systems and regulatory standards applicable to medical devices, such as ISO 13485 or FDA regulations.
• You demonstrate an excellent, proactive collaboration approach, take ownership for given tasks and demonstrate knowledge of problem-solving methods (e.g. 5Why, Ishikawa, 5W1H analysis) and statistical analysis.
• You have effective communication skills in English, both written and verbal, to collaborate with diverse teams.
• You are willing to travel up to 25% of the time to support quality-related activities across various sites.