Quality Inspector - III

Job Title: Inspector, Final QA Location: Medina, NY 14103 (Onsite) Duration: 06+ Month Contract with possible extension Schedule: Monday – Thursday | 5:30 AM – 4:00 PM Overtime: As needed on Fridays Position Overview: We are seeking a detail-oriented Final QA Inspector to perform final quality inspections and release activities for infusion pumps, wireless battery modules, and service parts in a regulated manufacturing environment. This role is responsible for reviewing Device History Records (DHR), inspecting products for compliance, documenting nonconformances, and ensuring products meet FDA and cGMP requirements prior to release. Key Responsibilities: Perform inspection of Device History Records (DHR) in paper and electronic Manufacturing Execution Systems (Camstar). Verify all testing procedures have been completed and release specifications have been met. Inspect infusion pumps and wireless battery modules for visual quality and labeling compliance. Approve product release within ERP systems (JDE B4ONE, JDE GME). Verify there are no open nonconformances associated with products prior to release. Review device history logs to ensure final testing is completed according to procedures. Record failures and observations accurately using Camstar and nonconformance systems. Disposition rework activities and complete electronic approvals and closures for nonconformances. Ensure process controls and maintenance procedures are followed. Identify out-of-compliance or out-of-tolerance conditions and take appropriate action. Inspect service parts and approve releases. Assist with identification and containment of nonconforming products during investigations and holds. Perform additional duties as assigned. Required (Must Have): High School Diploma or GED required. Experience in pharmaceutical, biotech, medical device, or regulated manufacturing environments preferred. Familiarity with cGMP and FDA requirements. Knowledge of measurement equipment and inspection processes. Experience with data entry, spreadsheets, and computer-based systems. Strong attention to detail and accuracy. Good verbal and written communication skills. Ability to visually inspect products, identify foreign material, and distinguish colors as required by FDA regulations. Ability to work overtime and flexible schedules when needed. Preferred (Nice to have / Not Required): Quality Assurance Inspection cGMP & FDA Compliance Camstar / Manufacturing Execution Systems Nonconformance Management ERP Systems (JDE) Documentation Review Root Cause Identification Quality Control Processes (YR - R1) #IND2 Employment Type: Full Time Salary: $20 - $25 Hourly Bonus/Commission: No