Arrotek Medical is a medical device engineering company offering a range of development and manufacturing services from initial design assessment, through to the provision of sterile finished product for the European and US medical device market. We strive to provide employees the opportunity to work in a competitive, growing and dynamic environment, for career development and employee wellness through providing a competitive employee package. For further information on Arrotek Medical, visit https://www.arrotek.com https://www.linkedin.com/company/arrotek-medical-ltd/.
We are currently recruiting for the position of Quality Engineer.
Qualifications and Education Requirements
- Minimum Degree in a Science or Engineering discipline.
- 3-5 Years’ experience working in a medical device environment in a Quality role.
- Strong knowledge of ISO 13485, FDA regulations 21CFR 820.
- Internal/external auditing experience would be an advantage.
- Validation experience including Sterilization, process and packaging validations would be beneficial.
- Knowledge of Medical Device manufacturing environment including cGMP would be an advantage.
- Understand general principles of ISO 14971.