Senior Quality Engineer

Job Description

Job Description

POSITION SUMMARY

The Senior Quality Engineer is responsible for supporting 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 Senior Quality Engineer provides QA support for the company by working with the Quality Assurance Manager to assure proper GMP compliance within Delcath Systems.

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.
• Develop and maintain Quality System procedures, including those governing quality control processes and product specifications
• Lead continuous improvements projects.
• Participate on new product design teams as the design assurance engineer.
• Implement and maintain risk management activities throughout the product lifecycle, including risk analysis (UFMEA, DFMEA, PFMEA) and control measures.
• Ensure proper creation, maintenance, and review of Technical Files and Design History Files (DHF) in compliance with regulatory requirements and design control processes.
• Perform and support design verification/validation, process validation, software validation and test method validation.
• Lead root cause investigations to identify issues and drive effective corrective actions.
• Conduct non-conformance activities, including containment, investigation, and disposition.
• Support the Corrective Action and Preventive Action Program.
• Support the Supplier Quality Program, including supplier evaluations, supplier corrective actions, and on-site quality audits.
• Conduct calibration investigation failures on equipment.
• Conduct customer complaint investigations.
• Support the Internal Audit Program through the performance of audits.
• Perform data and statistical trend analysis and support quality monitoring and metrics.
• Provides oversight for product releases, including finished products, raw materials, packaging components, and labeling.

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

• Bachelor’s degree in engineering or physical sciences is preferred.
• A minimum of five or more years of experience in quality assurance, quality engineering, 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. Experience with Minitab is preferred.
• 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.