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Quality Engineer III
Job Description
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
- 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 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)
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Staffing Leader of the Year Anju Abel
CEO, LanceSoft
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