Principal Quality Engineer

We are seeking an experienced Principal Quality Engineer to lead quality engineering initiatives that ensure compliance, product quality, and continuous improvement across manufacturing and product development processes. The ideal candidate will provide technical leadership in quality systems, risk management, validation, CAPA, supplier quality, and regulatory compliance while partnering with cross-functional teams to drive operational excellence. Responsibilities Lead quality engineering activities supporting product development, manufacturing, and sustaining engineering. Develop and implement quality strategies that comply with FDA, ISO 13485, ISO 9001, and other applicable regulatory requirements. Drive root cause investigations and corrective and preventive actions (CAPA) using structured problem-solving methodologies. Lead risk management activities including DFMEA, PFMEA, risk assessments, and mitigation plans. Review and approve engineering change orders (ECOs), design documentation, validation protocols, and quality records. Support design control activities including Design Verification & Validation (V&V), Design Reviews, and Design History Files (DHF). Analyze quality metrics and implement continuous improvement initiatives using Lean Six Sigma and statistical tools. Lead process validation activities including IQ, OQ, PQ, and process capability studies. Collaborate with Manufacturing, R&D, Regulatory Affairs, Supply Chain, and Operations to resolve quality issues. Provide technical leadership during internal, customer, and regulatory audits.```json” ```json { #J-18808-Ljbffr Katalyst CRO