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Clinical Quality Specialist

2 months ago


California, United States GForce Life Sciences Full time

Job Summary

We are seeking a highly skilled Clinical Quality Specialist to join our team at GForce Life Sciences. As a Clinical Quality Specialist, you will play a critical role in ensuring the quality and compliance of our medical device products.

Key Responsibilities

  • Support general audit administration, including tracking and following up on audit deliverables.
  • Support inspection readiness activities through quality checks and document reviews.
  • Provide general clinical study compliance-related support, including sponsor oversight activities and compliance-related questions.
  • Support procedure improvement opportunities and GCP training needs.
  • Support the implementation of quality systems in clinical research settings, including Corrective and Preventive Action activities (CAPA).

Requirements

  • Bachelor's degree in a scientific or engineering-related field.
  • Experience supporting clinical quality activities and ensuring GCP compliance in GCP and FDA-regulated activities.
  • Medical devices research experience is preferred but not mandatory.
  • Exposure to clinical research audits and/or quality system familiarity is an asset.

Preferred Qualifications

  • Certified clinical/quality auditor with ISO-13485 experience.

Benefits

  • Medical, dental, and vision benefits.
  • 401(k) plan.
  • Full-time position (40 hours/week).