QA Inspector

Job Description

Job Description

Title:               QA Inspector III

Location:       711 Park Ave, Medina NY 14103

Shift:              Monday through Thursday: 5:30am - 4:00pm
OT as needed on Friday

Job Description

Position Overview:

• As a Final QA Inspector, you will play a critical role in ensuring that our medical devices meet strict quality and regulatory standards prior to market release.
• You will be responsible for the final inspection and documentation review of infusion pumps and wireless battery modules in an FDA-regulated, temperature and humidity-controlled manufacturing environment.

Essential Functions:

• Perform the inspection of Device History Record (DHR) documentation for infusion pumps and wireless battery modules (either on paper or in the electronic Manufacturing Execution System, Camstar) to ensure test procedures have been completed and release specifications are met for final acceptance and release.
• Perform visual inspection of the pump or wireless battery module to ensure all visual aspects, including approved labels, are met prior to release.
• Approve the release of the pump and wireless battery modules in the appropriate ERP system (JDE B4ONE, JDE GME).
• Ensure there are no open nonconformances associated with the product in the approved nonconformance tracking system.
• Review the device history log within a pump to ensure final testing has been completed in accordance with applicable procedures.
• Accurately record all failing observations using the rework form in Camstar or the nonconformance system.
• Disposition the rework activities of nonconformances and complete the electronic approval and closure process.
• Ensure process control and maintenance procedures are being followed.
• Inspect Service Parts and approve the release of the parts.
• Assist with the identification and containment of nonconforming product on the floor for internal investigations and holds.
• Recognize out-of-compliance/out-of-tolerance situations and take appropriate action.

Qualifications, Knowledge, and Skills Required:

• Education: High School diploma or GED is REQUIRED.
• Experience: Previous experience in the pharmaceutical or biotech industry is highly preferred.
• Must be familiar with cGMP and FDA requirements.
• Knowledge and working application of measurement equipment, basic ESD requirements, and computer-based programs (data entry/spreadsheets).
• Demonstrated attention to detail, accuracy, and good communication skills.
• Ability to visually inspect and identify particulate/foreign matter and distinguish between colors as required by FDA Current Good Manufacturing Practices.
• Flexibility: May be required to work flexible hours and overtime on short notice.

Physical Demands:

• Must be able to sit for most of the workday, but also have the ability to stand or walk for long periods.
• Must have good hand-to-eye coordination and dexterity to perform repetitive motions with hands/fingers.
• Dynamic Lifting Capability: Must have the ability to lift and carry 25 pounds, and push/pull a maximum force of 5 pounds for 4 feet.

Work Environment & Safety Requirements:

This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the products we manufacture. Work rules include, but are not limited to:

• Wearing a static protective smock at all times while in the work area.
• Wearing a ground wrist strap and plugging that wrist strap into the working table if at an ESD-sensitive station.
• Working in close proximity to other employees.