QA technikus
Dolgozz te is Debrecen egyik legújabb gyártóvállalatánál!
Minőségügy
WHC013256 / Debrecen
Hivatkozási szám: WHC013256
Érdekel
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We are looking for a Quality System Engineer for our partner who manufactures medical technical aids in Vas County!
Tasks
- 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.
Expectations
- 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 5 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)
Our offer
- Multinational atmosphere
- Competitive salary
- Bonus twice a year
- Flexible work schedule
- Home office opportunity
- Excellent commuting support
We are looking for a Quality System Engineer for our partner who manufactures medical technical aids in Vas County!
