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Clinical Quality Specialist
2 months ago
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).