Quality Engineer II, Instrument Plant

Quality Engineer II will ensure compliance with ISO and regulatory requirements across the product lifecycle at an instrument manufacturing plant. The role involves maintaining documentation, analyzing quality data, supporting new product integration, and leading root cause investigations for medical devices.

Responsibilities

• Maintain ISO and regulatory compliance across design, manufacturing, assembly, testing, and inspection
• Develop and maintain Device History Files in full regulatory compliance
• Generate CTQ indices and provide recommendations to project teams and suppliers
• Support integration of new products into manufacturing and operations
• Lead root cause investigations and implement corrective actions for non-conformances and complaints

Requirements

• Bachelor's degree in Biological Sciences, Chemistry, or Regulatory Affairs
• 2 years quality assurance, quality control, or non-conformance investigation experience
• Medical device or pharmaceutical manufacturing facility experience
• SAP transaction experience
• Moderate knowledge of FDA 21 CFR 820, ISO 9000:2000, and ISO 13485:2003
• Data analysis using Six Sigma, root cause analysis, and risk assessment methods
• Proficiency in Excel, PowerPoint, and statistical software packages