What are the responsibilities and job description for the Quality Inspector I position at Medbio, LLC?
Summary of Function:
Quality Inspector I (QI) is responsible for the inspection and release activities for all manufactured products. The QI will assist with activities that support the manufacturing of components and finished goods.
The level I Quality Inspector is a beginning level position. The position requires math and problem-solving skills equivalent to a high school education. With readily available oversight, performs repetitive inspections following standardized methods and procedures. Is proficient in the areas of visual inspection and checks parts using a variety of precision measuring instruments or against fixed samples. Checks dimensions and finishes against drawings, product specifications, and/or customer specifications with basic knowledge of statistical sampling plans. Has basic skills to enter data in databases and other quality software. Communicate effectively with other departments verbally and other media such Microsoft Outlook. Basic use of Microsoft Applications. Perform responsibilities while applying and conforming to Quality System Management and Regulatory requirements.
Major Duties and Responsibilities:
The Quality Inspector (QI) reports to the Quality Manager about technical direction and training. The QI supports other Managers, Engineering, Manufacturing personnel, and technical staff in resolving specification and/or part-quality issues. Interact with management, engineers, maintenance, operators, assemblers, and customers to resolve product or process-related issues.
Experience and/or Educational Requirements:
Must be able to work a standard 40-hour work week, with occasional overtime and weekend work. Sitting and/or standing for extended periods of time as well as some walking within the facility. Must be able to have 20/20 vision with or without corrective lenses and distinguish color differences and depth perception for product and safety issues. Hearing ability should be sufficient to hear and react to audible alarms from distances up to 100 feet. Must be able to lift and carry various items up to 50 pounds.
Quality Inspector I (QI) is responsible for the inspection and release activities for all manufactured products. The QI will assist with activities that support the manufacturing of components and finished goods.
The level I Quality Inspector is a beginning level position. The position requires math and problem-solving skills equivalent to a high school education. With readily available oversight, performs repetitive inspections following standardized methods and procedures. Is proficient in the areas of visual inspection and checks parts using a variety of precision measuring instruments or against fixed samples. Checks dimensions and finishes against drawings, product specifications, and/or customer specifications with basic knowledge of statistical sampling plans. Has basic skills to enter data in databases and other quality software. Communicate effectively with other departments verbally and other media such Microsoft Outlook. Basic use of Microsoft Applications. Perform responsibilities while applying and conforming to Quality System Management and Regulatory requirements.
Major Duties and Responsibilities:
- Supports department metrics, 5S, and other department improvement projects.
- Perform sample-based inspections to meet requirements for:
- In-process releases
- Final releases
- Incoming releases
- Mold Repair Qualifications
- Efficiently and accurately enter test data in data collection software.
- Perform Job Folder reviews in a thorough and timely manner.
- Navigate and use the appropriate modules such as but not limited to MRB, Product move, Real Time Viewer, Lot disposition, mold repair qualifications.
- Efficiently measures products using basic equipment such as but not limited to calipers, micrometers, pin gages, height gages, optical comparators.
- Efficiently measures products using, but not limited to fixtures, pull testers, leak testers.
- Participates in Measurement Systems Analysis (MSA/GR&R) studies as needed.
- Basic knowledge of calibration requirements.
- Basic interpretation of blueprints.
- Set up and runs programs on advanced equipment such as CMM’s and scanning equipment.
- Provide coverage for departmental tasks when other team members are on vacation/absent.
- Assist in the implementation and/or improvement of new ideas, processes, and technologies.
- Basic use of Microsoft Applications such as Outlook, Excel, Word, PowerPoint.
- Perform other tasks assigned by the Quality Manager or Lead Inspector.
The Quality Inspector (QI) reports to the Quality Manager about technical direction and training. The QI supports other Managers, Engineering, Manufacturing personnel, and technical staff in resolving specification and/or part-quality issues. Interact with management, engineers, maintenance, operators, assemblers, and customers to resolve product or process-related issues.
Experience and/or Educational Requirements:
- High school diploma or GED equivalent.
- Preferred experience in plastics injection molding manufacturing or quality control.
- Basic computer skills (Microsoft Office & Outlook).
- Good blueprint reading skills with basic understanding of GD&T principles is preferred.
- Strong written/verbal communication, leadership, interpersonal and motivational skills.
- Good understanding of ISO and FDA regulations and cGMP requirements.
- Basic problem-solving skills.
Must be able to work a standard 40-hour work week, with occasional overtime and weekend work. Sitting and/or standing for extended periods of time as well as some walking within the facility. Must be able to have 20/20 vision with or without corrective lenses and distinguish color differences and depth perception for product and safety issues. Hearing ability should be sufficient to hear and react to audible alarms from distances up to 100 feet. Must be able to lift and carry various items up to 50 pounds.