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.
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Required Experience:
IC
HEALTHCARE NEEDS NEW ANSWERS Hospitals in the US are financially fragile and the pandemic has brought many to the verge of bankruptcy. Meanwhile, advancements in pharmaceuticals and medical technology carry the promise of better patient care – and a hefty price tag that threatens the ... View more