Quality Engineer

Role Overview

Join our Regulatory Affairs / Quality Assurance team as a Quality Engineer to investigate quality complaints, define quality requirements, and manage design changes. Work closely with Customer Care, Laboratory Operations, Product, and Engineering teams.

What You Will Do

Lead Post-Market Surveillance activities, investigate quality complaints, calculate defect rates, and prepare reports. Participate in product development teams, assess design impact, and manage design changes.

Why It Might Be a Fit

Minimum 3+ years of Quality Assurance / Regulatory Affairs experience in medical devices or CLIA-certified laboratories. Thorough understanding of 21 CFR 820, ISO 13485, IEC 62304, ISO 14971, and MDR/IVDR requirements.

Requirements

• Bachelor's degree in a relevant scientific or engineering discipline
• 3+ years of Quality Assurance / Regulatory Affairs experience in medical devices or CLIA-certified laboratories
• Thorough understanding of 21 CFR 820, ISO 13485, IEC 62304, ISO 14971, and MDR/IVDR requirements
• Demonstrated ability to identify and articulate risk to product quality and processes
• Proficiency in risk analysis tools and techniques (e.g. FMEA)
• Experience with design controls for laboratory equipment/ assays/ software

Benefits

• Market-based pay
• Base pay range: $110,000-$160,000