Regulatory Operations - Quality Engineer III

Responsibilities

• Driving preparation of KPI dashboards and maintaining a pulse on formal RA management review and internal metrics.
• Managing strategic programs for RA audit preparedness, including anticipatory identification of risks, mitigation of risks identified during the audit process, and preventive actions for risks.
• Investigating non-conformances (e.g., CAPAs), implementing mitigations, and monitoring effectiveness of CAPAs.
• Identifying and implementing system and/or systemic processes.
• Supporting tracking and maintenance of regulatory post-approval commitments.
• Driving quality system process improvement initiatives, including establishing audit risk mitigation activities for critical RA tasks, improving and maintaining quality system procedures (e.g., change management), and liaising with cross-functional partners and international affiliates to meet compliance needs.
• Participating in audit backrooms, and/or front rooms, and participating in RA projects.
• Exposure to Medical Device US and CE regulations, Quality Systems, a Quality role, or a Compliance role is a must.

Skills

• Independent Troubleshooting
• Critical Thinker
• Communication and Collaboration
• Ability to drive a problem through resolution and implement mitigations
• Ability to handle multiple streams simultaneously with timely execution