Quality Engineer

This role will provide compliance support to the Regulatory Affairs organization by: Driving preparation of KPI dashboards and maintaining a pulse on formal RA management review and internal metrics. Managing strategic program for RA audit preparedness including anticipatory identification of risks, mitigation of risks identified during the audit process, and preventive actions for risks. Supporting quality system integration for acquisitions and new product introductions. Identifying and implementing system and/or systemic processes. Supporting tracking and maintenance of regulatory post-approval commitments. Driving quality system process improvement initiatives. Initiatives include but are not limited to: Establishing audit support for integration products. Improving and Maintaining the quality system procedures (e.g., change managementntil). Liaising with cross-functional partners and international affiliates to meet compliance needs and driving to implementation/resolution. Participating in audit backrooms. Participating in RA projects. Qualifications: Degree with 3+ years of Regulatory Affairs & Quality Systems experience. Hands‑on exposure to medical device regulations (US FDA, CE), QMS processes (change management, CAPAs, post‑approval commitments), audit support, and regulatory audit preparedness from an RA or Quality perspective. Program execution & compliance operations strength — Ability to independently manage multiple workstreams, develop audit plans and KPIs, drive process improvements, troubleshoot compliance gaps, and work cross‑functionally to implement mitigations and sustain regulatory readiness. #J-18808-Ljbffr