Job Description

The Project Quality Engineer is responsible for ensuring the effective establishment and maintenance of the Delcath Quality System and ensuring that the facility is fully compliant to all applicable FDA, ISO regulations and the Medical Device Directives/Regulations.

The Project Quality Engineer is responsible for providing quality project management and support for the company by working with the Senior Quality Assurance Manager to assure proper GMP compliance within Delcath Systems.

PRIMARY DUTIES AND RESPONSIBILITIES:

• Project Management - lead continuous improvements projects.
• Participate on new product design teams as the design quality assurance engineer.
• Support design verification, process validation, software validation and test method validation.
• Generate procedures, specifications, and labeling as required.
• Support the Corrective Action and Preventive Action Program.
• Support the Internal Audit Program through the performance of audits as required.
• Support the Supplier Quality Program and perform on-site quality audits, as required.
• Support external regulatory audits.
• Understand and communicate component and finished product specification requirements.
• Support the Management Review process to monitor and evaluate Quality System effectiveness.
• Maintain effectiveness of the Quality Management System through the resolution of quality concerns and related issues as required.
• A minimum of Bachelor’s degree in engineering or physical sciences is preferred. 
• A minimum of five or more years of experience in quality assurance, quality engineering, project management or related functions in an FDA regulated industry or ISO certified organization is required.
• Must be team oriented, with the ability work well with diverse cross-functional teams.
• Must possess strong analytical and process skills, and be computer proficient in EXCEL, Word, etc.

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