Quality Control Inspector I
ZOLL Medical Corporation
Summary
In-Process and Final Inspection of all medical device products manufactured and distributed by ZOLL Medical to ensure conformance to specifications.
Job description
Job Summary
In-Process and Final Inspection of all medical device products manufactured and distributed by ZOLL Medical to ensure conformance to specifications.
Essential Functions
- Performs in-process and final inspection of all product lines and areas for conformance to specifications (inspection procedures and engineering drawings), conducting visual inspection and testing components/assemblies in production.
- Verify Calibration status of critical equipment and instrumentation.
- Maintains and records quality testing information as part of a DHR (Device History Record).
- Initiates DMR's (Discrepant Material Report) for nonconforming material.
- Understands and ensures compliance to procedures.
- Populate required inspection metric information.
- Prepare retain samples for storage.
- Completes all tasks within established guidelines. Understands and apply principles of GMP.
- Maintains work areas and equipment in a clean and orderly condition and follows prescribed safety regulations.
- Must be able to work in a Team environment, multi-task and communicate effectively.
Additional Responsibilities
- Inspect measure and/or test material to established methods and standards.
- Utilize various inspection tools, such as Vision System, Verniers, Micrometers, Rulers, Oscilloscopes, DVMs, Power Supplies, Defib/Pacer Analyzers, custom fixtures etc. per procedures.
- Document inspection and test results according to established procedures.
- Maintain quality documentation files such as, Device History Records (DHR) and Inspection History Records.
- Process returned material to established procedures.
- Read and interpret documentation such as Standard Operating Procedures (SOP), schematics, technical drawings, PDAs and ECOs.
- Interface with other functions and departments as required.
Requirements
- High School Diploma or equivalent required
- 1-3 years experience in a related position required
- Proficient in the English language (speak, read and write)
- Proficient in the use of basic Dimensional Measuring Tools
- Proficient in basic computer skills
- Ability to perform basic math calculations (addition, subtraction, multiplication and division)
- Ability to read specifications, procedures, and engineering drawings, basic blueprint reading
- Strong attention to detail
- Ability to lift up to 50 lbs
- Good written and oral communication skills
- Familiar with use of mechanical and electronic test equipment
- Basic computer skills: Microsoft Office, Oracle and MES
- IPC-A-610D for Incoming Inspection preferred
Benefits
- Comprehensive benefits plans
Company overview
ZOLL Medical Corporation, an Asahi Kasei Group company, is a global leader in acute critical care medical devices and software solutions. Founded in 1980 and named after Dr. Paul Zoll, the pioneering cardiologist known as "The Father of Modern Cardiac Therapy," the company develops innovative technologies that advance emergency care and save lives. ZOLL provides a comprehensive portfolio of medical devices and software solutions including defibrillators and cardiac monitors, CPR feedback systems, therapeutic temperature management devices, ventilation equipment, and sleep apnea diagnostic tools. The company's products are used worldwide by healthcare professionals, EMS and fire personnel, and lay rescuers to treat patients with serious cardiopulmonary and respiratory conditions. ZOLL's flagship products include the LifeVest wearable cardioverter defibrillator, which has protected over one million patients, and the remedē System for treating central sleep apnea. With a focus on improving clinical outcomes and operational efficiencies, ZOLL combines cutting-edge technology with comprehensive training and support services to empower medical professionals and improve patient care across the continuum of emergency response and critical care.