Quality Inspector II
Goleta, CA, US, 93117
JOB SUMMARY:
Performs the Final Check Out (FCO) inspection and testing of KSI products, third party devices and in-house commodities and to ensure that they meet or exceed specifications. Helps to validate inspection and test procedures, methodologies, and equipment. Performs required tasks as directed by immediate supervisor/lead and department management.
ESSENTIAL FUNCTIONS:
- Ensures that all KSI purchased and in-house commodities conform to Engineering drawings/specifications using nondestructive inspection/testing techniques.
- Performs Final Check Out (FCO) of systems, heads, chassis and accessories.
- Visually inspects KSI purchased and in-house commodities to ensure conformance to internal workmanship standards.
- Assists in the validation of inspection and testing procedures, methodologies, and equipment as part of new product development, pilot builds, and daily operations.
- Maintains quality records related to the conformance and nonconformance of KSI purchased and in-house commodities.
- Assists in ensuring that product flow is maintained to meet schedule requirements.
- Assist with SAP/Fiori transactions.
- Conducts (Manage, control and carry out trough completion) limited training of personnel on inspection/testing methods and procedures within in process for production, service and FCO departments.
- Assists in the final inspection of the DHR and processing QM lots for units packed prior releasing them to shipping.
- Ensures the identification and control of nonconforming material and, when required, participates in the processing of nonconforming material through MRB.
- Regular attendance is an essential job function.
- Will spend part of his/her time as a member of continuous improvement teams undertaking projects and seeking ways to improve the quality of KSI’s products and services.
ADDITIONAL RESPONSIBILITES:
- Assist in ensuring that KSI quality systems meet the overall objectives of KARL STORZ.
- Performs other related duties as assigned by supervisor.
KNOWLEDGE, SKILLS, ABILITIES:
- Knowledge of medical device quality system regulations and standards (eg, U.S. FDA Quality System Regulation 21CFR Part 820, ISO13485, ISO9001)
- Understands AQL sampling procedures.
- Basic math.
- Proficient in utilizing common “off the shelf” mechanical measuring and electronic test equipment (video experience a plus but not mandatory).
- Able to read and comprehend engineering and production procedures to perform the inspection requirements as written.
- Able to perform simple computer related functions for the entry and query of information.
- Ability to read, comprehend, and analyze data supplied by manufacturers as part of inspection.
- Assist in ensuring that KSI quality systems meet the overall objectives of KARL STORZ.
EDUCATION AND EXPERIENCE:
- High school diploma or equivalent.
- 3 to 5 years of experience in electronics manufacturing and inspection environment.
- Good written and oral communication, in English.
PHYSICAL & MENTAL REQUIREMENTS:
- Manual dexterity and good eyesight to perform delicate and precise tasks.
- Ability to lift approximately 30 pounds, and to stand for moderate amounts of time (2-3 hours per day)
About the Company
Located just north of Santa Barbara on the scenic Central Coast of California, KARL STORZ Imaging in Goleta designs and manufactures high tech medical imaging equipment including video cameras and image enhancing devices. We employ technical staff with expertise in electronics, optics, mechanical systems and software. Our lean manufacturing operations include an in-house machine shop which enables the complete on-site assembly of our products. To become a part of this dynamic team, we invite you to learn more about our opportunities.
KARL STORZ is committed to maintaining a safe work environment for our employees and customers. Most field-based roles at KARL STORZ require hospital credentialing/health screens as a condition of employment. Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers. During the interview process, we encourage you to ask how credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.
The pay range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future. When determining a specific team member’s base salary and/or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.
KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences. To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status, or any other protected characteristic. KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at taoperations@karlstorz.com.
Nearest Major Market: Santa Barbara
Nearest Secondary Market: Santa Maria