Contingent Worker Regulatory Operations Quality Engineer III

ICONMA, LLC

Santa Clara, CA

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JOB DETAILS

SALARY

$41.78–$45.65 Per Hour

SKILLS

Auditing, Change Management, Change Order Management, Corrective Action, Cross-Functional, File Audits, Health Plan, Healthcare, Identify Issues, Maintain Compliance, Medical Equipment, Metrics, Performance Metrics, Problem Solving Skills, Process Improvement, Project/Program Management, Quality Engineering, Quality Management, Regulations, Reporting Dashboards, Risk Analysis, Risk Management, Systems Maintenance, Technical Writing, Time Management

LOCATION

Santa Clara, CA

POSTED

27 days ago

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

Contingent Worker Regulatory Operations Quality Engineer III

ICONMA, LLC

Santa Clara, CA

About the Company

ICONMA, LLC

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