Quality & Regulatory Compliance
Own and maintain the site Quality Management System (QMS) in alignment with:
FDA QMSR (21 CFR 820 – ISO *****:**** aligned)
ISO ***** and applicable global regulations
Monitor and implement regulatory updates (FDA, ISO, international) and translate them into actionable site requirements.
Ensure QMS documentation is current, effective, and audit-ready.
Audits & Inspections
Lead and host:
FDA inspections
ISO / registrar audits
Customer audits (medical device OEMs)
Own audit preparation, execution, response, and closure.
Develop and track CAPAs to ensure root cause effectiveness and prevention of recurrence.
Risk Management & CAPA
Ensure robust risk management practices across:
Manufacturing processes
Material changes
Supplier changes
Lead investigations for quality events, deviations, and escapes.
Ensure CAPAs are data-driven, systemic, and aligned with regulatory expectations.<...