Quality Engineer

Delcath Systems Inc•Town of Queensbury, NY

32d•$65,000 - $75,000•Onsite

About The Position

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

Requirements

Bachelor’s degree in engineering or physical sciences is preferred.
A minimum of two or more years of experience in quality assurance, quality engineering, or related functions in an 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 verbal and written communication skills.
Must be willing to travel.
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.
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.

Nice To Haves

Experience with Minitab is preferred.

Responsibilities

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.