Quality Systems Engineer

Delcath Systems Inc•Town of Queensbury, NY

49d

About The Position

We’re looking for a motivated and collaborative Quality Systems Engineer 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. POSITION SUMMARY The Quality Systems Engineer is responsible for routine management and coordination of the Delcath Documentation Quality System. The overall purpose of the position is to ensure that FDA, EU GMP and ISO 13485 Quality System requirements and Company procedures are followed, and, if needed, that Company procedures are revised for compliance. The Quality Systems Engineer must demonstrate a high level of involvement in continuous improvement activities to ensure the highest standards are maintained. The Quality Systems Engineer must possess ability to solve practical problems and deal with a variety of situations in a fast-paced environment.

Requirements

A minimum of a bachelor’s degree in engineering or physical sciences is required.
A minimum of three or more years of experience in quality assurance of an FDA regulated or ISO 13485 certified organization.
Must possess strong knowledge of computerized Document Control Systems.
Must have experience in audit support, document control, change control, CAPA, NCR.
Must be team oriented, with the ability to work well with diverse cross-functional teams.
Must possess strong analytical and process skills, and be computer proficient in EXCEL, Word, etc.
Must possess strong verbal and written communication skills.
Must be willing to travel on occasion.

Nice To Haves

Certification in internal/external auditing an advantage
Ideally have auditor experience and auditor certification.

Responsibilities

Maintain effectiveness of the Quality Management System through the resolution of quality concerns and related issues as required.
Manages the Document Change control process (ECN); development, approval, issuance, revision, distribution, maintenance, use, storage, security, and disposal of critical Delcath documents (specifications, procedures, work instructions, labeling) for the Queensbury and Galway sites.
Responsible for managing external standards.
Manages/supports the Supplier program.
System administrator for the Document Management System
Supports quality systems software validations.
Supports technical file maintenance and submissions to Notified Body.
Manages the preparation, submission, and maintenance of all labeling/labeling-related projects.
Maintain archive of change-controlled labeling including creation of summary of change or labeling annotations to be used in the change control process and maintained in labeling archive for submission to regulatory agencies.
Coordinates the annual review of all controlled documentation.
Creates/revises BOMs and Routings in ERP system.
Responsible for issuing Training requirements through the Document Management System.
Support the Corrective Action and Preventive Action program and NCR program.
Supports the Internal Audit Program and performance of audits as required.
Support external audits.
Support Management Review process to monitor and evaluate Quality System effectiveness.
Develop and maintain a working knowledge of FDA cGMP and 21CFR 820 regulations and Clinical trial (EU) regulation 536/2014 supplemented by GMP regulation 2017/1569 and EU GMP guidelines for IMPs (December 2017).
Support Post Market Surveillance program.
Support quality and regulatory projects.