Quality Assurance Technician

We’re looking for a motivated and collaborative Quality Assurance Technician 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 Assurance Technician position is responsible for performing duties that help to organize and maintain an effective quality system. The overall purpose of the position is to support the company goal of ensuring that Delcath is fully compliant to all applicable FDA, ISO and EU GMP regulations.

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

• Responsible for monitoring and confirming manufacturing process activities


• Review Device/Drug Routing’s to support Manufacturing operations


• Perform/review line clearance activities to support Manufacturing operations


• Responsible for reviewing manufacturing records and verifying data


• Perform final product inspection and final release activity


• Responsible for organizing and performing Incoming Inspection duties


• Assists and performs quality investigations with supervision


• Manages CAPAs with supervision


• Supports the EU Clinical Trial supply process


• Supports the Calibration and preventative maintenance activities.


• Support the CAPA and NCR program.


• Supports the Internal Audit Program through the completion of audit actions as required.


• Support external regulatory audits.


• Assists with the monthly metric review process 


• Other duties as assigned

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 cause undue hardship.

EDUCATION and/or EXPERIENCE

• Minimum recognised 3rd level qualification (Certificate/Diploma) in a Science related discipline.


• 3 year QA experience in medical device field or equivalent


• Must possess strong analytical and process skills, and be computer proficient in EXCEL, Word, etc.


• Must possess strong verbal and written communication skills.

The Quality Assurance Technician has no supervisory responsibilities.

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.