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Quality Systems Engineer

2 months ago

Temecula, United States The Fountain Group Full time
Job DescriptionJob Description

This role will provide compliance support to the Regulatory Affairs 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.
  • Supporting quality system integration for acquisitions and new product introductions.
  • 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:

  • Establishing audit support for integration products,
  • Improving and Maintaining the quality system procedures (e.g., change management)

 

Role has a potential for investigating nonconformances (CAPAs) and implementing mitigations. Exposure to Medical Device US and CE regulations, Quality Systems, a Quality role, or a Compliance role is a plus.

 

List of tasks:

  • RA Change Requests Tracking and Closure
  • Change management
  • 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.
  • Post-Approval Commitments management
  • Support QMS audits from an RA perspective
  • Support QMS Integration tasks
  • Management Review Metrics results
  • Ability to drive a problem through resolution and implement mitigations.
Company DescriptionThe Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.

Browse our website below for additional information on our company.

The Fountain Group

4505 Woodland Corporate Blvd, Tampa, FL 33614
“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”Company DescriptionThe Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.\r
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Browse our website below for additional information on our company.\r
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The Fountain Group\r
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4505 Woodland Corporate Blvd, Tampa, FL 33614\r
“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”