Delcath Systems · 8 hours ago
Project Quality Engineer
Queensbury, NY
Full-time
Onsite
Senior Level
5+ years expDelcath Systems is focused on quality management within the medical device industry, and they are seeking a Project Quality Engineer to ensure compliance with FDA and ISO regulations. The role involves leading quality projects, supporting design verification, and maintaining the Quality Management System.
BiotechnologyHealth CareOncologyPharmaceutical
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
Qualification
Required
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
Preferred
A minimum of Bachelor's degree in engineering or physical sciences is preferred
Company
Delcath Systems
Delcath Systems is an interventional oncology company that focuses on the treatment of metastatic liver cancer.
51-200 employees
H1B Sponsorship
Delcath Systems has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Public CompanyTotal Funding
$292.9MKey Investors
Vivo CapitalAvenue Capital GroupSilicon Valley Bank
2024-12-30Post Ipo Equity· $16.3M
2024-03-15Post Ipo Equity· $7M
2023-09-01Post Ipo Equity· $35M
Leadership Team
G
Gerard J. Michel
Chief Executive Officer
Martha Rook
Chief Operating Officer
Recent News
Business Wire
2026-01-11
2026-01-11
BioWorld Financial Watch
2026-01-04
Company data provided by crunchbase