Quality Engineer

• Bachelor’s degree in quality, manufacturing, engineering, or related medical device field
• Experience in a Quality role within a manufacturing environment
• Experience managing a QMS in accordance with ISO 13485 or other ISO standards (9000 or 9001)
• Hands-on experience with CAPA, root cause analysis, and quality metrics
• Interface with customer and internal staff to resolve quality issues
• Proven ability to lead internal and external audits, including customer, supplier, and registrar audits
• Experience interpreting engineering drawings and using inspection equipment
• Knowledge of medical device manufacturing or regulated industries (preferred)
• Familiarity with Lean Manufacturing, Theory of Constraints, or Six Sigma

Responsibilities

• Lead the management and ongoing improvement of the Quality Management System to ensure compliance with ISO 13485 and applicable customer/regulatory standards.
• Serve as the primary point of contact for quality-related communications, manage customer complaints, investigations, and resolution processes.
• Oversee document control, calibration, and validation activities to support manufacturing and compliance efforts.
• Lead internal and external audits, report findings to executive leadership, and support continuous improvement initiatives.
• Drive root cause analysis, CAPA execution, and supplier quality performance to maintain product integrity and meet quality standards.