Title: Regulatory Quality Engineer
Duration: 12 Months
Location: Santa Clara, CA 95054
 
Description / Summary:
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.

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 CE 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 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 46.00/hr.