Quality Systems Engineer at Delcath Systems Inc – Queensbury, New York

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 include the following. Other duties may be assigned.

• 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 an Associate’s degree is required. A Bachelor’s degree in engineering or physical sciences is preferred,
• A minimum of three or more years of experience in quality assurance, or related functions in a FDA regulated industry or ISO certified organization is required
• 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 knowledge of computerized Document Control Systems (MasterControl would be an advantage).
• Must possess strong verbal and written communication skills.
• Must be willing to travel.

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.