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.

• 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.

• 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 work streams, develop audit plans and KPIs, drive process improvements, troubleshoot compliance gaps, and work cross‑functionally to implement mitigations and sustain regulatory readiness.