Quality System Engineer
Válasz a hirdetésreSCHOTT is a leading international technology group in the areas of specialty glass and glass-ceramics. With more than 130 years of outstanding development, materials and technology expertise we offer a broad portfolio of high-quality products and intelligent solutions. SCHOTT is an innovative enabler for many industries, including the home appliance, pharmaceutical, electronics, optics, life sciences, automotive and aviation industries. SCHOTT strives to play an important part of everyone’s life and is committed to innovation and sustainable success. The parent company, SCHOTT AG, has its headquarters in Mainz (Germany) and is solely owned by the Carl Zeiss Foundation. As a foundation company, SCHOTT assumes special responsibility for its employees, society and the environment. ,
- Ensures with his/her supervisor that the requirements of the relevant standards and guidelines are dealt with: relevant cGMP, ISO 9001 - Quality Management System (QMS), ISO 15378 - Primary Packaging Pharmaceuticals, ISO 13485 - Medical Devices, pharmacopoeias and other guidelines in the pharmaceutical environment.
- ISO 9001, ISO 15378, ISO 13485 - maintenance of certification status, monitoring of requirements, taking actions Participation in improvements, preparation for the audits, maintenance of the documents, managing changes.
- Support for planning and conducting internal audits, creating (+following up) the associated audit reposts and CAPA items, creation and monitoring / updating of the annual Internal Audit Program.
- Owner of CAPA management tool (software for CAPA management) and the related process. Issuing CAPAs, reviewing and approving CAPA results.
- Supporting maintenance of Document management system based on the Process Map
- BSc or MSc in the field of any engineering or nature science, quality management, food or pharmaceuticals
- Quality experience in a manufacturing environment, minimum of 3 years in Quality Management System
- Good command of English
- Deviation and problem solving skills
- High proficiency in QMS standards, including ISO 9001; advantage: ISO 13485, ISO 15378 GMP and other pharmaceutical guidelines, SAP
- M365 knowledge
- Experience regarding auditing (internal or supplier)
At SCHOTT, you can expect a unique corporate culture where we emphasize equity, diversity, and inclusion. We know: motivated and committed employees are the precondition for the success of our company.
At SCHOTT, it’s your personality that counts – not your gender, your identity, or origin.
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