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Contingent Worker Regulatory Operations – Quality Engineer III

Iconma

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
25 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?

About the Company

I

Iconma

ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.

  • Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
  • Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
  • Founded in 2000
  • 2000+ Employees

The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Management Consulting Services
EMPLOYEE BENEFITS
401K, Employee Referral Program, Life Insurance
FOUNDED
2000
WEBSITE
https://www.iconma.com/