Join our team as a
Sterilization Expert
ESP-Mataró (Barcelona)
Take advantage of your new scope of action in the Quality Area at HARTMANN.
Responsibilities
- Support in the sterilization validation projects and sterile packaging products of the HARTMANN products
- Management of sterilization lots release in routine with the outsourced sterilizers
- Participation in supplier audits, especially in the sterilization area
- Support in the QA management system according to ISO 13485 and MDR, documentation, microbiological control plans, procedures, and QA projects
- Support in specific projects of HSE (like sustainability report, green point and plastic tax declaration)
What do we look for?
- University degree on Chemical Engineering, Pharmacy, Bio-medical Engineering or Biology, or similar
- Understanding of applicable guidelines and regulations associated to the sterilization methods EO and radiation, for example experience on EN 11135, ISO 11607
- Strong knowledge of medical device regulations, in focus MDD and MDR legal requirements expertise or similar regulated industry
- Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
- Minimum 1-3 years of experience in a regulated industry in a similar role.
- Very good knowledge of Spanish and English written and spoken.
Are you ready for an internationally successful company? Do you appreciate the benefits of an outstanding market position? Then start your career at HARTMANN now. With us, attractive framework conditions and excellent training opportunities await you. After all, our greatest potential is your personal development.
Department: Quality
If you are interested in the position please register beforehand and send us your CV through the "Apply now" option below.
Once registered, you will be able to send any questions about the requested profile to Ricard Monfort.
Email: Ricard.Monfort@hartmann.info
Join our team as a
Sterilization Expert
ESP-Mataró (Barcelona)
Take advantage of your new scope of action in the Quality Area at HARTMANN.
Responsibilities
- Support in the sterilization validation projects and sterile packaging products of the HARTMANN products
- Management of sterilization lots release in routine with the outsourced sterilizers
- Participation in supplier audits, especially in the sterilization area
- Support in the QA management system according to ISO 13485 and MDR, documentation, microbiological control plans, procedures, and QA projects
- Support in specific projects of HSE (like sustainability report, green point and plastic tax declaration)
What do we look for?
- University degree on Chemical Engineering, Pharmacy, Bio-medical Engineering or Biology, or similar
- Understanding of applicable guidelines and regulations associated to the sterilization methods EO and radiation, for example experience on EN 11135, ISO 11607
- Strong knowledge of medical device regulations, in focus MDD and MDR legal requirements expertise or similar regulated industry
- Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
- Minimum 1-3 years of experience in a regulated industry in a similar role.
- Very good knowledge of Spanish and English written and spoken.
Are you ready for an internationally successful company? Do you appreciate the benefits of an outstanding market position? Then start your career at HARTMANN now. With us, attractive framework conditions and excellent training opportunities await you. After all, our greatest potential is your personal development.
Department: Quality
If you are interested in the position please register beforehand and send us your CV through the "Apply now" option below.
Once registered, you will be able to send any questions about the requested profile to Ricard Monfort.
Email: Ricard.Monfort@hartmann.info