Job Title: Quality Assurance Engineer

Location: United States (Onsite)

This position is open exclusively to people who are eligible to work in USA

Overview:

We are seeking a Quality Assurance Engineer to support quality systems and ensure compliance in regulated environments. The role focuses on maintaining product quality, supporting audits, and driving continuous improvement initiatives.

Required Experience:

• 3+ years of experience in Quality Assurance within Pharma / Medical Device / Life Sciences industry
• Strong knowledge of GMP and FDA regulations (21 CFR Part 11 / 21 CFR Part 820)
• Experience with deviation, CAPA, and change control processes
• Hands-on experience with quality documentation and audits
• Knowledge of ISO 13485 and/or ISO 9001 standards
• Experience in root cause analysis and risk management
• Familiarity with validation and qualification processes

Key Responsibilities:

• Ensure compliance with GMP, FDA, and quality standards
• Manage and review deviations, CAPA, and change control records
• Support internal and external audits and regulatory inspections
• Review and approve quality documentation including SOPs and reports
• Conduct root cause analysis and implement corrective/preventive actions
• Collaborate with cross-functional teams to ensure product quality
• Support continuous improvement and quality system enhancements