Primary function of position
The Senior Final Quality Inspector (FQI) will perform visual and functional inspections and will perform testing processes on in-house manufactured endoscopes. This position requires a highly motivated 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 define disposition based on the inspection results.
- Perform simulated procedures utilizing a surgical robotic system and accessories. Use test equipment/fixtures as required.
- Detect functional and visual defects (non-conformities)
- Document inspection results in SAP and perform inspection operation Sign-Off in SAP
- Accurately record detailed observations of non-conformances in the Device History Records
- Follow procedures for product non-conformances records origination (NCR’s), documentation practices and escalation process. Create and edit NCR Task for FQI in SAP.
- Handle product in accordance with procedures to prevent mix-ups, damage, or other adverse effects.
- Communicate inspection results to appropriate personnel (QA Supervisor, Quality Engineering, Manufacturing)
- Perform other duties as may be assigned.
Required Knowledge, Skills, and Experience:
- Minimum 2 years working experience in Quality Inspection / Quality Control / Quality Assurance in a manufacturing environment.
- Language Skills: Ability to read and comprehend instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to other employees, supervisors, or engineers. English language skills preferred.
- Reasoning Ability: Ability to apply commonsense understanding to carry out instructions. Ability to deal with standardized situations with only occasional or no variables. Ability to understand the basic material flow from the stock room to finished goods, Bill-of-Material structure, and cycle counting procedures. Ability to report quality issues. Ability to suggest process improvements.
- Computer skills: Ability to use personal computers as part of daily work including MS Office suite. Ability to use systems (SAP/Agile would be an advantage) to document results and check procedures, training. Ability to use on-line documentation.
Experience with SAP in a product test / quality assurance process or similar would be an advantage. Experience in a document control system.
- Other skills and abilities: Ability to work in a team environment and with cross-functional teams. Ability to work varying shifts. Must have ability to complete training courses.
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.
