CR-Quality Engineer II

Role focuses on establishing and improving quality assurance practices and procedures for medical device manufacturing. Responsibilities include leading validation transfers (IQ/OQ/PQ and related activities), reviewing validation protocols, providing on-the-line QA support, investigating nonconforming material and driving CAPA/disposition, drafting procedures to implement quality requirements, applying DMAIC for non-conformance investigations, selecting inspection gauges and sampling strategies, auditing processes (internal and supplier) for quality and regulatory compliance, collaborating with suppliers to ensure incoming material quality, developing quality metrics, and contributing to process improvement projects including Quality planning, risk analysis, and FMEA. The position also involves guidance and training in statistical analysis techniques and installation/operational/performance qualification protocols.