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six sigma audits qms iso 13485 capa📋 Description
- Maintain the approved supplier list and supplier audit schedule.
- Drive compliance with QMS requirements and supplier corrective actions.
- Conduct external and internal audits to identify risks and drive improvement.
- Lead quality agreements with critical suppliers and maintain supplier records.
- Engage with Freenome suppliers to drive quality and process improvements.
- Lead processing of supplier change notifications.
🎯 Requirements
- Bachelor's degree in life science or equivalent experience.
- 5+ years in manufacturing ops, clinical lab ops, quality, or supplier quality.
- ISO 13485 Lead Auditor or CQA certification.
- Effective problem solving; escalate concerns to management.
- Proficiency with Word/Excel/PowerPoint or Google Workspace and document mgmt systems.
- Ability to prioritize, multitask, and maintain a collaborative attitude.
🎁 Benefits
- Hybrid work model with potential for local travel.
- Family Medical Leave Act (FMLA) resources.
- Equal Employment Opportunity (EEO) resources.
- Employee Polygraph Protection Act (EPPA) resources.
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