Overview
Quality Control Analyst (Microbiological Testing) Jobs in Tampa, FL at Bausch + Lomb
Responsibilities:
Prioritize timely completion and remediation of Corrective Action and Preventive Action (CAPA) performing investigations, corrections, corrective actions, preventive actions and effectiveness checks.
Perform review and remediation of Nonconforming Records and Product Holds
Maintain, monitor and report trend analysis information on assigned products.
Develop and maintain a robust process for identifying and monitoring root cause failure modes, frequency, and severity.
Maintain and remediation process failure mode effects analysis (pFMEAs) for the products.
Support returned product analysis and failure investigation activities for manufactured products (explant lab).
Conduct all engineering activities in compliance with FDA’s Quality System Regulation, Medical Device Directive (MDD), ISO 13485, Canadian CMDR, and other quality and regulatory requirements and standards.
Demonstrate high level engineering thought processes that are based on both driving business objectives and product quality improvements.
Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
Requirements:
Engineering degree or BS/MS (i.e. mechanical, electro-mechanical, electrical, etc.) or equivalent experience.
7+ years of experience in medical device quality, preferably in remediation.
Working knowledge of FDA QSRs, 13485 and 14971.
Ability to manage multiple stakeholders and competing priorities.
Key Required Experience:
FDA CFR 820.
ISO 13485.
Supply chain/factory experience.
NCM.
Receiving Inspection.
Product holds.
CAPA/root cause analysis.
Title: Quality Control Analyst (Microbiological Testing)
Company: Bausch + Lomb
Location: Tampa, FL
