QC Inspector

The QC Inspector performs sampling, inspection, testing, and sampling of incoming materials; conducts required in-process and final inspection of reprocessed devices their packaging; performs pre- and post-sterilization inspection of batches and review of Batch Production Records (BHRs). Strictly follows and enforces established procedures and policies needed to meet the demands of Quality in a regulated medical device company.

Essential Duties and Responsibilities :

• Perform inspections of purchased components, reprocessed devices and their packaging, sterilization records, and Batch History Records (BHRs) to controlled procedures and pre-determined acceptance criteria.
• Accurately document the results of the inspections and testing.
• Participate in the creation and / or revision of procedures for the inspection function.
• Ensures appropriate labeling, storage and handling of product and materials throughout the manufacturing facility to prevent mix-ups.
• Ensures Quarantine areas are orderly maintained and scrapping requests made by the Materials Review Board (MRB) are fulfilled.
• Responsible for updating material status in ERP system following the completion of Quality activities.
• Ensures line clearance and material reconciliation activities are conducted as dictated by company procedures.
• Assist with nonconforming product investigations, CAPAs, and customer complaints.
• All other reasonable duties, as assigned.

Education, Qualifications and Skills :