Quality Assurance Technician

Delcath Systems Inc•Town of Queensbury, NY

4d•$23 - $25•Onsite

About The Position

We’re looking for a motivated and collaborative Quality Assurance Technician to join our growing team at Delcath. In this role, you’ll have the opportunity to make a meaningful impact while working alongside talented colleagues in a supportive and innovative environment. We're excited to provide a complete benefits package, including a comprehensive health plan, 401(k), and professional development opportunities, to support the well-being and growth of our employees and their families. The Quality Assurance Technician position is responsible for performing duties that help to organize and maintain an effective quality system. The overall purpose of the position is to support the company goal of ensuring that Delcath is fully compliant to all applicable FDA, ISO and EU GMP regulations.

Requirements

Minimum recognised 3rd level qualification (Certificate/Diploma) in a Science related discipline.
3 year QA experience in medical device field or equivalent
Must possess strong analytical and process skills, and be computer proficient in EXCEL, Word, etc.
Must possess strong verbal and written communication skills.
Ability to read and interpret documents such as technical journals, safety rules, operating and maintenance instructions, and procedure manuals.
Ability to write routine reports and correspondence.
Ability to speak effectively with employees and outside organizations.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
Ability to compute rate, ratio, and percent and create and/or interpret spreadsheets and graphs.

Responsibilities

Responsible for monitoring and confirming manufacturing process activities
Review Device/Drug Routing’s to support Manufacturing operations
Perform/review line clearance activities to support Manufacturing operations
Responsible for reviewing manufacturing records and verifying data
Perform final product inspection and final release activity
Responsible for organizing and performing Incoming Inspection duties
Assists and performs quality investigations with supervision
Manages CAPAs with supervision
Supports the EU Clinical Trial supply process
Supports the Calibration and preventative maintenance activities.
Support the CAPA and NCR program.
Supports the Internal Audit Program through the completion of audit actions as required.
Support external regulatory audits.
Assists with the monthly metric review process
Other duties as assigned