Job Description

Quality Assurance Engineer | 12+ Month Contract

Skaneateles, NJ 13153 (hybrid- 3 days onsite and 2 days remote)

About the Role:

We’re seeking a Quality Assurance Engineer to join our team on a 12+ month contract . You’ll play a vital role in ensuring product safety and regulatory compliance by investigating quality issues, analyzing complaint trends, and driving corrective and preventive actions.

Key Responsibilities:

• Investigate and analyze quality complaints using multiple system inputs.
• Determine risk levels and root causes for complaints using defined coding structures.
• Analyze quality data (e.g., Field Corrective Actions, MDRs) to identify trends or systemic issues.
• Review investigation reports for GMP compliance; strategize to close documentation gaps.
• Lead and support CAPAs using formal problem-solving methodologies.
• Monitor continuous improvement activities and product quality metrics.
• Recommend enhancements to existing quality systems and processes.

What You Bring:

• Bachelor’s degree in Engineering (required).
• 1–3 years of medical device industry experience.
• Strong knowledge of quality systems, CAPA processes, and FDA regulations.
• Analytical mindset and attention to detail.
• Effective communication skills for cross-functional collaboration.

Why Join Us?

Be part of a mission-driven team improving lives through quality and compliance in medical devices. This is a great opportunity to contribute meaningfully while gaining valuable industry experience in a regulated environment.

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