Contingent Worker Regulatory Operations - Quality Engineer III

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.
• Establishing audit risk mitigation activities for critical RA tasks.
• Improving and maintaining quality system procedures (e.g., change management).
• Liaising with cross-functional partners and international affiliates to meet compliance needs and driving to implementation/resolution.
• 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.
• 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

Requirements:

• 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

Why Should You Apply?

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities