Validation Engineer I
Core
Execute supplier qualification, monitoring, audits, and corrective actions to ensure global supply base compliance with FDA regulations and ISO standards.
Role type
Supplier Quality Engineer (IC)
Builds
Supplier quality records, audit reports, and compliance documentation for medical device/drug supply chains.
Domain
Medical Devices / Regulatory Quality
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Supplier auditing, SCAR management, root cause analysis, risk management, documentation review, regulatory compliance knowledge (FDA/ISO), statistical process control, quality tools (FMEA, PPAP, APQP)
Preferred skills
ASQ CQE certification, Certified Supplier Quality Professional, Six Sigma Green Belt, supplier audit hosting experience
Technologies
None explicitly stated
Responsibilities
Conduct supplier audits for ISO 9001/13485 compliance, support supplier qualification and disqualification, review and approve supplier quality records, execute Supplier Corrective Action Requests (SCARs), provide technical guidance and training to suppliers, support containment activities for nonconformances, maintain audit and performance records, prepare routine performance reports.
Seniority
Mid-level, hands-on IC