Primary function of the position:
The Final Quality Inspection (FQI) Technician will perform visual and functional inspections and will perform testing processes on inhouse manufactured endoscopes. This position requires a team player to support quality screening for endoscopes by simulating functional use identifying potential quality issues and working cross functionally with manufacturing and quality engineering teams to identify issues prior to product release.
Roles and Responsibilities:
- Conduct visual and functional inspection of endoscopes to QAP procedures or specifications and disposition based upon results
- Perform simulated procedures utilizing a surgical robotic system and accessories. Use test equipment/fixtures as required.
- Detect and document functional and visual defects (nonconformities)
- Document inspection results and error description in SAP
- Accurately record detailed observations of nonconformances in the Device History Records
- Follow procedures for product nonconformances (NCRs) records origination documentation practices and escalation processes
- Handle product in accordance with procedures to prevent mixups damage or other adverse effects
- Communicate inspection results to appropriate personnel and inform about deviation if necessary
- Perform other duties as may be assigned
Qualifications :
Required Knowledge Skills and Experience:
- Completed technical training or comparable technical activity with two years of adequate professional experience in the field of quality assurance or comparable.
- Good visual abilities to detect imaging errors
- Strong awareness of quality and quality processes
- Good communication and documentation skills in German and English language skills preferred.
- Advanced knowledge of common MS Office products and ERP / Document Control Systems (preferably SAP/ACCS)
- Ability to understand Medical Device QMS Corporate DOPs quality assurance procedures (QAPs) and regulatory requirements including but not limited to ISO13485 desirable
- a pronounced awareness of quality order and cleanliness
- Ability to understand the basic material flow from the stock room to finished goods BillofMaterial structure and cycle counting procedures
- Independent responsible and reliable way of working combined with a distinct ability to work in a team environment and with crossfunctional teams flexibility and a high willingness to learn
- Ability to work varying shifts
- Suitability to work in a clean room under ESD conditions as well as at microscope workstations
Additional Information :
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Remote Work :
No
Employment Type :
Fulltime