Company Description
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
Job Description
Primary function of the position:
The Final Quality Inspection (FQI) Technician will perform visual and functional inspections and will perform testing processes on in-house 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 (non-conformities)
- Document inspection results and error description in SAP
- Accurately record detailed observations of non-conformances in the Device History Records
- Follow procedures for product non-conformances (NCR’s) records origination, documentation practices and escalation processes
- Handle product in accordance with procedures to prevent mix-ups, 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 DOP’s, 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, Bill-of-Material 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 cross-functional 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.
Shift: Day
Travel: None
