Job Description

Now Hiring: Quality Assurance Engineer

Location: Skaneateles, NY

Duration: 12+ Months (Potential for Extension)

Shift: 1st Shift | Full-Time (40hrs/week) | Hybrid

Start ASAP

Are you ready to play a critical role in ensuring product quality and patient safety in the medical device industry? We’re seeking a motivated and detail-oriented Quality Assurance Engineer to join a top-tier medical device manufacturer in Skaneateles, NY.

About the Role:

As a Quality Complaint Investigation Engineer, you'll be responsible for reviewing product complaints, performing root cause analysis, and ensuring compliance with FDA and ISO standards. You’ll directly support continuous improvement efforts and work hands-on with product and process data to drive quality excellence.

Key Responsibilities:

• Investigate and document product complaints using data from FCA, FDA MDRs, service reports, and more.
• Perform root cause analysis and assign accurate cause/problem codes.
• Prepare and present risk assessments and data-driven investigation reports.
• Identify compliance gaps and develop strategic corrective plans.
• Lead or support CAPA processes, including problem-solving and documentation.
• Recommend and support improvements to the quality system.

Qualifications:

• Bachelor’s degree in Engineering (Required).
• 1–3 years of experience in medical devices or regulated industry.
• Working knowledge of 21 CFR 820, FDA cGMP, and ISO/ASQC standards.
• Strong skills in root cause analysis, technical drawing interpretation, and use of Minitab or other statistical tools.
• Proficient with Word, Excel, PowerPoint, Access, and database tools.
• Excellent organizational and multi-tasking abilities.

Why Join Us?

• Be part of an industry-leading, FDA-regulated company known for innovation and quality
• Gain hands-on experience in complaint investigation and quality systems
• Collaborate in a cleanroom, team-oriented, and compliance-driven environment
• Work on meaningful products that impact patient lives globally

Ideal for early-career engineers who are passionate about quality , compliance , and making a real difference in healthcare.

📩 Ready to launch your next opportunity? Apply now or message me directly for more details!

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