Our client, a Medical Device and Healthcare company, is looking for a Contingent Worker Regulatory Operations – Quality Engineer III for their Santa Clara, CA location. Responsibilities:

+ This role will provide quality system and compliance support to the Regulatory Affairs (RA) 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.

+ 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. ...