Company DescriptionAt 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 DescriptionPrimary function of positionThe 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 disposition based upon 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 / 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.
Temporary work in manufacturing (e.g., calibration line)
Perform other duties as may be assigned.
QualificationsRequired Knowledge, Skills, and Experience:
Hands-on technician with at least 2 years working experience in Quality Inspection / Quality Control / Quality Assurance environment with working knowledge of GMP and GDP or applicable successfully completed apprenticeship or similar.
Language Skills: Ability to read, write and understand Bulgarian. 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 Medical Device QMS, Corporate DOP's, quality assurance procedures (QAPs) and regulatory requirements. 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 simple process improvements.
Computer skills: Ability to use personal computers as part of daily work including MS Office suite. Ability to use systems (SAP/Agile) 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. 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.Additional InformationIntuitive 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.
