Description

Support manufacturing operations and ensure product and process compliance with ISO 9001, FDA regulations, and internal quality standards.

This role is on-site.

Responsibilities

• Apply Quality Engineering methodologies to improve compliance and operational effectiveness.
• Conduct root cause investigations and develop corrective and preventive actions (CAPAs).
• Support internal, customer, and regulatory audits, ensuring timely closure of findings.
• Lead and manage Validation, Calibration, and Environmental Monitoring Programs.
• Review, revise, and maintain SOPs, reports, and supplier records.

Required Skills

• Bachelor's degree in Engineering or a related scientific field.
• 3–5 years of experience in Quality Engineering within a regulated environment.
• Strong background in root cause analysis and risk management.
• Experience using ERP/QMS platforms, specifically Epicor ERP.
• Proficiency with Microsoft Office applications.
• Experience conducting and supporting internal/external audits.
• Technical writing capabilities.

Key Skills

Education

Bachelor's degree