Careers

Queensbury, NY

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.

To apply for this position, please send your resume to jobs@delcath.com.

Queensbury, NY

We are searching for an experienced Administrative Assist to provide general administrative and clerical support for multiple managers, greet persons entering the building, deal with queries from public and customers, record keeping, file maintenance, and data entry. Supports executive team with travel and expenses.

ESSENTIAL DUTIES AND RESPONSIBILITIES 

• Provide administrative support for the team

• Coordinate detailed travel plans and itineraries, compile documents for travel-related meetings

• Maintain confidentiality of all corporate, personnel and research matters

• Communicate as requested, with individuals at various levels of responsibility

• Schedule and coordinate meetings, appointments for managers and supervisors

• Coordinate activities with other departments as needed

• Maintain various databases and spreadsheet files as requested

• Create, maintain and selectively distribute marketing contact lists

• Help organize, prepare and maintain expenses and expense reports

• Reconcile corporate credit card account(s)

• General clerical duties

• Prepare agendas for meetings and prepare schedules

• Assist in updating power point presentations

• Other duties may be assigned.

To apply for this position, please send your resume to jobs@delcath.com.

Queensbury, NY

We are searching for an experienced Quality Manger for the oversite of the day-to-day medical device manufacturing activities including supplier control oversite, incoming and in-process quality inspection, NCR/CAPA/Complaint review approval and product release.  Provides direct tactical Quality support for multiple projects within Delcath Systems, Inc. to provide execution of the development, launch and post-approval maintenance of medical device components and finished medical devices according to the approved Design Control procedures.

ESSENTIAL DUTIES AND RESPONSIBILITIES 

• In coordination with Senior Director of Quality, develop and execute quality and regulatory strategies and systems to comply with Quality System Regulations (QSR), Medical Device Directive (MDD), International Standards Organization (ISO), Recognized Consensus Standards and all other applicable quality system requirements. Ensure compliance to 21 CFR Part 820, 21 CFR Part 211, 21 CFR Part 4, ISO 13485, MDR 2017/745, UK MDR 2002, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Manage and maintain the effectiveness of the Delcath Quality Management System at the Queensbury sites and manage the resolution of all quality concerns and related issues as required. Act as the Deputy Management Representative for Queensbury.
• Execute day-to-day processes for medical device manufacturing facility QA accountabilities to ensure continual regulatory compliance with FDA, Outside US Regulatory Authorities, and Notified Body and Approved Body requirements.
• Provide oversight for product releases: finished products, raw materials, packaging components, and labeling.
• 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 Customer Complaint investigations. Ensure Customer Complaint records are properly maintained, followed-up, and closed.
• Support the Routine Metric Review and the Management Review process to monitor and evaluate Quality System effectiveness.
• Maintain current knowledge base of all regulatory and quality assurance related changes within the industry.
• Provide Quality leadership to development teams.  Represents the Quality discipline by providing support to all Sustaining Engineering Projects.
• Work closely with internal regulatory staff and external consultants to prepare, review medical device manufacturing documentation for domestic and international paper-based and electronic regulatory submissions. 
• Collaborate with the Regulatory Team to recommend and implement regulatory strategies for product line extensions in support of product development team efforts and provide guidance to those teams to ensure that development activities are consistent with overall regulatory strategy.
• Review and interprets technical and scientific data to ensure regulatory requirements are met; evaluates product/design and process changes for potential effect upon product safety and effectiveness; appropriately document Quality disposition of such changes.
• Review and maintain Quality Systems programs to ensure continuous improvement and regulatory compliance.
• Other duties may be assigned.

To apply for this position, please send your resume to jobs@delcath.com.