Quality Engineer of Design and Development (mfd)
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Job Summary
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 2200 employees worldwide together we will meet tomorrows challenges today.
- 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.
- 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.
Curious Apply now!
We are interested in finding the best candidates and they may come from a nontraditional background. So please dont hesitate to apply even if you arent an exact fit. We look forward to getting you started on your employment journey with Heraeus Medevio!
Any further questions
Our Recruiting Team Heraeus Medevio is happy to assist you by email: . Or visit us at .
Required Experience:
IC
About Company
The Heraeus Group is a broadly diversified and globally leading family-owned technology company, headquartered in Hanau, Germany. The company’s roots go back to a family pharmacy started in 1660. Today, Heraeus bundles diverse activities in the Business Platforms Metals and Recycling, ... View more
