Quality Systems Engineer

Delcath Systems; Town of Queensbury (NY); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Comprehensive health plan

401(k)

Professional development opportunities

Job summary

A healthcare technology company in Queensbury is seeking a Quality Systems Engineer to manage the Quality Management System and ensure compliance with FDA and ISO standards. The role involves resolving quality concerns and supporting audits. Candidates should have a bachelor's degree in engineering, three years' experience in a regulated environment, and proficiency in document control systems. The position offers a comprehensive benefits package including health coverage and 401(k).

Qualifications

• Minimum of three years of experience in quality assurance of an FDA regulated or ISO 13485 certified organization.
• Experience in audit support, document control, change control, CAPA, NCR.
• Certification in internal/external auditing is an advantage.
• Team-oriented with the ability to work with cross-functional teams.

Responsibilities

• Manage the Quality Management System and resolve quality concerns.
• Coordinate Document Change control processes and support quality systems software validations.
• Support internal and external audit programs.
• Develop knowledge of FDA cGMP and EU GMP regulations.

Skills

Problem-solving

Analytical skills

Strong communication

Team collaboration

Computer proficiency in Excel and Word

Education

Bachelor's degree in engineering or physical sciences

Tools

Document Control Systems

ERP System

Job description

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.

ESSENTIAL DUTIES AND 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.

SUPERVISORY RESPONSIBILITIES

The Quality Systems Engineer has no supervisory responsibilities.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions, unless they constitute undue hardship.

EDUCATION and/or EXPERIENCE

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

LANGUAGE 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.

MATHEMATICAL SKILLS

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.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to sit, stand or walk and talk or hear. The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms; and is subject to repetitive motions of the wrists, hands, and/or fingers. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, heat, airborne particles, moderate noise and outside weather conditions.