Job Title: Quality Engineer

Location: USA (Onsite)

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

Overview:

Seeking a Quality Engineer with 3–4 years of experience in the medical device industry to support quality assurance activities, compliance, and continuous improvement initiatives in a regulated environment.

Required Experience:

• 3–4 years of experience in Quality Engineering within medical device or regulated industry
• Strong knowledge of FDA regulations (21 CFR Part 820) and ISO 13485
• Experience with CAPA, NCR, and Root Cause Analysis
• Hands-on experience in validation (IQ/OQ/PQ) and process improvements
• Familiarity with risk management (FMEA) and documentation control

Key Responsibilities:

• Support quality systems to ensure compliance with regulatory and company standards
• Lead and participate in CAPA investigations and root cause analysis
• Review and maintain quality documentation including SOPs and validation reports
• Collaborate with cross-functional teams on process improvements and audits
• Assist in internal/external audits and ensure timely closure of findings