Remote

We are searching for an experienced Executive Assistant to provide general administrative and clerical support for multiple managers, direct queries from public and customers, record keeping, file maintenance, and data entry. Supports executive team with travel and expenses.

PRIMARY DUTIES AND RESPONSIBILITIES:

• Provide administrative support for the team.
• Coordinate detailed travel plans and itineraries, compiles 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.
  Maintains various databases and spreadsheet files as requested.
• Create, maintain and selectively distribute marketing contact lists.
• Help to 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

The Production Coordinator will assist in the manufacture of disposable medical devices by fabricating, assembling, inspecting, labeling and packaging various medical device components. In addition, they will be responsible for the creation of labels and assist the Production Supervisor in the creation of production orders as needed.

ESSENTIAL DUTIES AND RESPONSIBILITIES 

• Fabricate, assemble, inspect, label & package medical device components and products to consistently high-quality standards as directed
• Strictly follow written procedures and maintain product and lot identification in accordance with company policies and good manufacturing practices
• Print product labels ensuring accuracy and legibility.
• Timely notify the supervisor when documentation or procedural errors are noticed and provide recommendations for continuous improvement to comply with FDA and other regulatory requirements
• Maintain accurate records for work performed
• Understand and utilize measurement instruments to verify work quality
• Perform project work, as assigned, for the Research and Development and Operations Departments
  
• Contribute to and maintain a professional and respectful work environment
• Assist Production Supervisor in the creation of production orders and ERP transactions.
• Other duties may be assigned.

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

Hybrid Remote/Queensbury, NY

The Human Resource Generalist will assist with the daily functions of the Human Resource (HR) department including hiring and interviewing staff, administering pay, benefits, and leave, and enforcing company policies and practices.

PRIMARY DUTIES AND RESPONSIBILITIES:

• Review, track, and document compliance with mandatory and non-mandatory training, continuing education, and work assessments. This may include safety training, anti-harassment training, professional licensure, and aptitude exams and certifications.
• Recruit, interview, and facilitate the hiring of qualified job applicants for open positions; collaborate with departmental managers to understand skills and competencies required for openings.
• Conduct or acquire background checks and employee eligibility verifications.
• Implement new hire orientation and employee recognition programs.
• Perform routine tasks required to administer and execute human resource programs including but not limited to compensation, benefits, and leave; disciplinary matters; disputes and investigations; performance and talent management; productivity, recognition, and morale; occupational health and safety; and training and development.
• Handle employment-related inquiries from applicants, employees, and supervisors, referring complex and/or sensitive matters to the appropriate staff.
• Attend and participate in employee disciplinary meetings, terminations, and investigations.
• Maintain compliance with federal, state, and local employment laws and regulations, and recommended best practices; review policies and practices to maintain compliance.
• Maintain knowledge of trends, best practices, regulatory changes, and new technologies in human resources, talent management, and employment law.
• Perform other duties as assigned.

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

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.

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.