Senior Inspector , Quality Control; THV; 2nd Shift

Job Title: Senior Inspector, Quality Control (THV)

• Senior Inspector I, Quality Control (THV)
• Senior Inspector II, Quality Control (THV)
• Senior Inspector III, Quality Control (THV)

• Manufacturing - Hourly
• Responsible for supporting the Quality department with quality control activities related to the manufacture of the THV.

• Perform Quality Control inspection activities related to THV manufacturing, including functional inspection, visual inspection, final inspection, packaging inspection, and final release activities, in accordance with approved procedures and production requirements.
• Support day-to-day QC inspection priorities by completing assigned inspection tasks accurately, efficiently, and in alignment with production schedules.
• Review in-process and finished product documentation, including manufactured valve DHRs, Jasmine preparation records, inspection records, and ancillary logs, as applicable, to ensure completeness, accuracy, and compliance with Good Documentation Practice (GDP) requirements.
• Support review and release activities for THV Device History Records and final product release documentation in accordance with established quality requirements.
• Identify, document, and communicate inspection discrepancies, documentation errors, nonconforming material, or quality concerns in a timely manner to QC supervision, Quality Engineering, Manufacturing, or other applicable functions.
• Support Material Review Board (MRB) activities by providing inspection results, documentation review input, and product status information related to nonconforming material, as applicable.
• Perform inspection-related activities in support of Engineering, R&D, validation, process development, and special projects, as assigned.
• Assist with training, onboarding, and qualification of QC Inspectors by providing hands‑on guidance, procedure walkthroughs, inspection technique support, and feedback, as appropriate.
• Maintain certification and qualification for applicable QC inspection activities, including functional, visual, final inspection, packaging, and release‑related processes.
• Support adherence to Good Manufacturing Practices (GMP), Good Documentation Practice (GDP), document control, record retention requirements, and applicable Quality Management System procedures.
• Verify that inspection equipment, tools, fixtures, and work areas are ready for use, properly maintained, and within calibration or preventive maintenance requirements prior to use.
• Support preventive maintenance and calibration coordination for QC equipment, including Vivitro, BDC, or other inspection/test systems, as applicable.
• Provide clear and timely communication to QC supervision and cross-functional stakeholders regarding inspection status, documentation issues, product holds, release status, training needs, and quality concerns.
• Serve as a technical resource for QC inspection processes by demonstrating strong procedural knowledge, attention to detail, and consistent application of acceptance criteria.
• Ensure compliance with site Health & Safety requirements and maintain safe working practices within QC inspection areas.