Principal Quality Engineer

Position Title: Principal Quality Engineer Work Arrangement: Onsite Position Summary: Take personal ownership and processing of designated high-complexity, high-visibility CAPAs while driving overall CAPA process acceleration across the site portfolio. Provide guidance, coaching, and day-to-day technical direction to additional CAPA personnel — including the contract Sr. Quality Engineers — balancing workload and reviewing investigations, action plans, and effectiveness checks prior to routing. Support the CAPA Chair: prepare CAPA Review Board materials, pre-screen records for board readiness, present portfolio status and aging, and follow through on board decisions and commitments. Key Responsibilities: Support Quality System updates and modifications, leading or approving revisions to CAPA procedures, templates, and training content, and performing gap analysis against ISO 13485, 21 CFR 820/QMSR, and MDSAP expectations. Ensure documentation compliance across the CAPA subsystem — record integrity, traceability, and audit readiness of all closed and in-flight records. Apply risk-based decision-making to determine the impact of systemic nonconformities on the QMS, product, and process, and to set the appropriate scope and depth of corrective action. Connect CAPA outcomes to the broader quality system — complaints, NCs, internal/external audit findings, risk management, and Management Review — to identify and close systemic gaps. Preferred : Act as SME during FDA inspections, Notified Body, and customer audits: defend CAPA records, draft and negotiate audit responses, and manage follow-up commitments to closure. Qualification & Experience: #J-18808-Ljbffr