Quality Engineer III

Title: Regulatory Operations - Quality Engineer III
Location: Santa Clara, CA - 95054
Duration: 12 Months

Description / Summary:
This role will provide quality system and compliance support to the Regulatory Affairs (RA) organization by -

1. Driving preparation of KPI dashboards and maintaining a pulse on formal RA management review and internal metrics.
2. 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.
3. Investigating non-conformances (e.g., CAPAs), implementing mitigations, and monitoring effectiveness of CAPAs.
4. Identifying and implementing system and/or systemic processes.
5. Supporting tracking and maintenance of regulatory post-approval commitments.
6. Driving quality system process improvement initiatives.

Initiatives include but are not limited to:
1. Establishing audit risk mitigation activities for critical RA tasks.
2. Improving and maintaining quality system procedures (e.g., change management).
3. Liaising with cross-functional partners and international affiliates to meet compliance needs and driving to implementation/resolution.
4. Participating in audit backrooms, and / or front rooms, and
5. Participating in RA projects.


Exposure to Medical Device US and Client regulations, Quality Systems, a Quality role, or a Compliance role is a must.


List of tasks:

• Develop and implement an "auditing plan" for critical RA tasks (e.g., mock audits for Technical Files/Technical Documentations, Impact Assessments, Archival) as part of audit risk mitigation activities.
• CAPAs/Auding Finding management.
• Key Performance Indicator results / metrics management
• Change management (change orders for procedural updates)
• Post-Approval Regulatory Commitments management
• Support QMS audits from an RA perspective
• Support QMS Integration tasks

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.

Experience:
5 - 7 years


Location:
Onsite (Santa Clara, CA)