Quality Engineer

Responsibilities

• Develop and execute validation protocols (IQ/OQ/PQ), capability studies, and risk analyses (pFMEA).
• Support First Article Inspections, customer requirements, and regulatory compliance.
• Manage nonconformance investigations, CAPA, and supplier corrective actions.
• Develop and maintain quality documentation, test methods, and process standards.
• Provide support to manufacturing teams during process changes and quality issues.
• Assist with audits, customer complaints, and training of staff on quality methods.

Requirements:

• Bachelor's degree in engineering or related experience in Quality Assurance.
• Strong knowledge of ISO 13485, FDA QSR, and validation requirements (IQ/OQ/PQ).
• Experience with GD&T, metrology, statistical analysis, and quality tools.
• Excellent communication, problem-solving, and cross-functional collaboration skills.