🚨 Hiring: Quality Assurance Engineer (Complaint Investigation) 🚨

📍 Location: Skaneateles, NY (Hybrid)

📅 Duration: 9-Month Contract

👩 💻 Experience: 1–3 Years

⭐ Local candidates preferred

We are currently looking for a Quality Assurance Engineer to support complaint investigation and quality system activities within a medical device manufacturing environment . This role is ideal for early-career engineers with strong analytical and investigation skills.

🔹 Key Responsibilities:

• Investigate product complaints and perform root cause analysis

• Review service data and determine risk levels for reported issues

• Analyze quality data including Complaints, MDRs, and Field Corrective Actions (FCA)

• Drive CAPA activities and continuous improvement initiatives

• Identify gaps in GMP compliance and support remediation strategies

• Prepare investigation reports and quality analysis summaries

• Support quality system improvements and maintain compliance with regulatory standards

🔹 Required Qualifications:

• Bachelor’s Degree in Engineering

• 1–3 years of experience in a Medical Device or regulated manufacturing environment

• Knowledge of FDA cGMP and 21 CFR 820

• Experience with CAPA, root cause investigations, and complaint handling

• Familiarity with Minitab or statistical analysis tools is a plus

• Strong analytical, documentation, and problem-solving skills