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six sigma fmea qms dmaic capa📋 Description
- Lead QA operations and quality systems to ensure regulatory compliance.
- Manage product/system investigations; apply RCA and Six Sigma for CAPAs.
- Oversee Receiving Inspection, batch release, and data review.
- Ensure ALCOA+ data integrity and regulatory/document control.
- Lead audits, inspections, and support regulatory readiness.
- Coach QA staff and drive continuous improvement.
🎯 Requirements
- Bachelor's in Science/Engineering; 7–10 yrs pharma QA exp.
- 4+ yrs in QA leadership/management roles.
- Experience with FDA inspections and third-party audits.
- Strong knowledge of cGMP, 21 CFR Parts 11/210/211; ICH Q7–Q10.
- Proficient RCA, CAPA, DMAIC, FMEA; data integrity (ALCOA+).
- Knowledge of QMS, deviation/CAPA, document mgmt, ERP.
🎁 Benefits
- On-site role in Johnson City, TN with office-based work.
- May require extended/off-shift hours for regulatory inspections.
- May require domestic or international travel for audits/training.
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