Quality Design Engineer - ISO13485 Medical Devices
Descrizione dell'offerta
QUALITY DESIGN ENGINEER
(ISO13485 MEDICAL DEVICES)
Permanent Opportunity
ASAP Start
OVERVIEW:
Would you like embark on a thrilling journey with a passionate team dedicated to revolutionizing patient care through the power of surgical robotics?
Do you crave the fast-paced environment of the Surgical Robotics Industry?
Our client is seeking a remarkable individual with an insatiable passion for innovation and an unwavering commitment to excellence.
Join them as a Quality Design Engineer and be part of an truly exciting stage for our medical device client, at the forefront of breakthrough technology.
Are you driven by curiosity, always eager to learn and grow?
KEY ACCOUNTABILITES:
The main purpose of the role is to work with the R&D Electrical Engineering team and update Quality Documentation when there is a change to the process:
- Support the engineering team for developing verification test plans and reports
- Updating the documentation and process involving internal stakeholders and external notified bodies.
- Support quality system-related deliverables, including nonconformances and CAPAs
SKILLS/EXPERIENCE REQUIRED:
- Degree educated from either Life Science or Engineering
- Experience working with active medical devices (Class IIa/IIb would be a preferred)
- Knowledge of ISO 13485, having worked 2+ years within a Quality Department in a Medical Technology company
- ISO 14971 Risk Management knowledge would be good too.
- IEC 60601* standards would also be a strong preferred
- EU MDR and FDA knowledge would be great too
- Italian speaker and must speak at least B1 English
If you have not heard back from Projectus within 7 days please assume that your application has been unsuccessful on this occasion only.