Quality Engineer

About the role

The Quality Engineer supports the effective establishment and maintenance of the Delcath Quality System and ensures full compliance with FDA, ISO regulations, and Medical Device Directives/Regulations.

Responsibilities

• Maintain effectiveness of the Quality Management System through the resolution of quality concerns and related issues.
• Develop and maintain Quality System procedures, including those governing quality control processes and product specifications.
• Lead continuous improvements projects.
• Participate on new product design teams as the design assurance engineer.
• Implement and maintain risk management activities throughout the product lifecycle, including risk analysis (UFMEA, DFMEA, PFMEA) and control measures.
• Ensure proper creation, maintenance, and review of Technical Files and Design History Files (DHF) in compliance with regulatory requirements and design control processes.
• Perform and support design verification/validation, process validation, software validation and test method validation.
• Lead root cause investigations to identify issues and drive effective corrective actions.
• Conduct non-conformance activities, including containment, investigation, and disposition.
• Support the Corrective Action and Preventive Action Program.
• Support the Supplier Quality Program, including supplier evaluations, supplier corrective actions, and on-site quality audits.
• Conduct calibration investigation failures on equipment.
• Conduct customer complaint investigations.
• Support the Internal Audit Program through the performance of audits.
• Perform data and statistical trend analysis and support quality monitoring and metrics.
• Provides oversight for product releases, including finished products, raw materials, packaging components, and labeling.

Qualifications

• Education and/or Experience: Bachelor’s degree in engineering or physical sciences preferred; at least two or more years of experience in quality assurance, quality engineering, or related functions in an FDA regulated industry or ISO certified organization.
• Skills: Team-oriented, strong analytical and process skills, computer proficiency in EXCEL, Word, and Minitab, strong verbal and written communication skills, willingness to travel.