AOT is a strongly growing Swiss MedTech company dedicated to the development of robotic laser osteotomes and novel surgical workflows that will revolutionize the field of bone surgery. To enable our targeted growth trajectory, we are currently seeking a qualified
QA Engineer (m/f)
In this position you work closely with the design engineers (HW and SW). You will be responsible to support the design engineers in writing QA/RA-compatible documentation (acc. to EN ISO 13485:2016 and MDR) and to support the production department. Together with the QA Manager you are responsible to foster the work according to the quality and regulatory requirements.
Duties and Responsibilities
- Active support of the design engineers during product life-cycle regarding the quality and regulatory requirements
- Ensure that the design documents conform to the regulatory requirements.
- Representation of quality aspects and quality requirements as well as the normative and statutory requirements within the design department
- Document results from the design engineers
- Responsible for the QA/RA-compliant design process
- Execution of internal design reviews
- Support the QA-Manager in the daily business
- Participating in internal and external audits
- Responsible for Non conformities and CAPAs
- Responsible for the Supplier Management
- Support the production department regarding qualification and validation
Beside your ability to work in a small high-tech team, you take the personal responsibility and show willingness to learn; the ideal candidate should meet the following criteria:
- Technical education (electronics and/or software), Bachelor Degree or equivalent qualification would be an asset
- Knowledge in electronic design/assembly/production would be an asset
- Knowledge of the standard family IEC 60601-1
- Experience in a medical device company preferred
- Knowledge of EN ISO 13485, MDR, 21 CFR 820, EN ISO 14971 etc. would be an asset
- Amicable, hands on, open minded, good listener, solution provider
- Very good understanding for complex technical systems
- Analytical mind and systematic working and
- Good command of German and English required;
We offer a competitive compensation and flexible working conditions. We are a young and dynamic company with flat hierarchies where your input makes a difference.
Your working location will be in the center of Basel (5 minutes’ walk from Basel SBB).
Herr Tobias Straumann