Quality System Manager at Delcath Systems Inc – Queensbury, New York

We're looking for a motivated and collaborative Quality Systems Manager 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

Responsible for ensuring the effective establishment and maintenance of the Delcath Quality System and ensuring that the facility is fully compliant to all applicable national and international regulations and standards. Responsible for maintaining the quality system in an audit ready state.

This position retains signatory authority for Quality Management.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

In coordination with Director of Quality, develops and executes quality and regulatory strategies and systems to comply with Quality System Regulations (QSR), Medical Device Regulation (EU MDR 2017/745), International Standards Organization (ISO), Recognized Consensus Standards and all other applicable quality system requirements. Ensures compliance to 21 CFR Part 820, 21 CFR Part 211, 21 CFR Part 4, ISO 13485, UK MDR 2002, other regulatory requirements, company policies, operating procedures, processes, and task assignments.Manages and maintains the effectiveness of the Delcath Quality Management System and manages the resolution of all quality concerns and related issues as required. Execute day-to-day processes for medical device manufacturing facility regulatory accountabilities to ensure continual regulatory compliance with FDA, Outside US Regulatory Authorities, and Notified Body and Approved Body requirements.Lead Regulatory/Notified Body audits at the Queensbury site and provides support for Regulatory/Notified body audits at the Galway siteManages the Corrective Action and Preventive Action Program.Manages the Internal Audit Program.Manage the Supplier Quality Program.Support Customer Complaint investigations. Ensure Customer Complaint records are properly maintained, followed-up, and closed.Manages the Management Review process to monitor and evaluate Quality System effectiveness.Support the Post Market Surveillance process for the US and OUS markets.Maintains current knowledge base of all regulatory and quality assurance related changes within the industry.Monitor, review and interpret new or revised medical device regulatory requirements and proactively advise colleagues. Supports new OUS country product registrations and manages existing country registration activities.Review and interpret technical and scientific data to ensure regulatory requirements are met; evaluate product/design and process changes for potential effect upon product safety and effectiveness; appropriately document regulatory disposition of such changes. Manages these change notifications with the Notified Body and Approved Body.Review and maintain Quality Systems programs and provide Site Regulatory SOPs to support business activities.