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.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
Number of Employees
11-50 employees