Job Description
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
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:
Skills:
Experience:
5 7 years
Location:
Onsite (Santa Clara, CA)
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)
Numbers & Facts
| Location | Santa Clara, CA |
| Industry | Staffing/Employment Agencies |
| Salary | $45 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.
Skills
- Auditingunmatched
- Change Managementunmatched
- Change Order Managementunmatched
- Corrective Actionunmatched
- Cross-Functionalunmatched
- File Auditsunmatched
- Identify Issuesunmatched
- Maintain Complianceunmatched
- Medical Equipmentunmatched
- Metricsunmatched
- Performance Metricsunmatched
- Problem Solving Skillsunmatched
- Process Improvementunmatched
- Project/Program Managementunmatched
- Quality Engineeringunmatched
- Quality Managementunmatched
- Regulationsunmatched
- Reporting Dashboardsunmatched
- Risk Analysisunmatched
- Risk Managementunmatched
- Systems Maintenanceunmatched
- Technical Writingunmatched
- Time Managementunmatched
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