Quality Systems Specialist (m/f/d)

Quality Systems Specialist (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:

• In your role you will support the Head of Quality and the site in CAPA, final product release and document control.
• Identifying corrective action plans (CAPA) is your responsibility, you coordinate and moderate them and monitor their realization and effective implementation. You will gladly take over the implementation in our software platform.
• In your function you plan internal and supplier audits, process them and create the documentation; you administrate and archive audit reports reliably for our site.
• You will coordinate and support the areas of customer complaints as well as supplier monitoring and requalification, thus ensuring the implementation of our quality system.
• You have a passion for numbers, key figures and for trend analyses and can provide these for management reviews.

Your profile:

• You hold a degree (min. Bachelor) in natural sciences, biomedical engineering, mechatronics or related subjects.
• Ideally, you have experience in quality, CAPA management/quality assurance in controlled industries such as medical technology, pharmaceutical industry, automotive industry, aerospace (ideally at least 3 years) and enjoy specialized training and further education.
• Basic knowledge of the relevant standards (e.g. ISO 13485/ 21CFR820 / ISO 14971) complete your profile.
• You have a good command of written and spoken German and English, are a pro-active and well organized team player and enjoy working in an international environment where you can demonstrate your excellent communication skills.
• A qualification as an internal auditor as well as knowledge of root cause analysis / problem solving methods (e.g. 5Why, Ishikawa) are desirable.