Job Details
Ganesh Devasoth
Contact Person Details
Sandeep Reddy
INT22602 - Manufacturing line Quality Engineer
Role: Quality Engineer
Location: Scarborough, ME - 04074
Duration: 3 Months
The position of Manufacturing Line Quality Engineer is within our Infectious Disease
Developed Markets business unit located at Westbrook, Maine. In this role you will provide
support for product quality assurance, process improvements and all quality system program at
the Westbrook Site.
This job description will be reviewed periodically and is subject to change by management.
Developed Markets business unit located at Westbrook, Maine. In this role you will provide
support for product quality assurance, process improvements and all quality system program at
the Westbrook Site.
This job description will be reviewed periodically and is subject to change by management.
RESPONSIBILITIES:
Support production with resolution of quality issues in accordance with established
procedures.
Support production on the manufacturing floor, ensuring adherence to procedures and
ensure appropriate device history record (DHR) documentation. Supports line
clearances, reworks, and inspections as required.
Demonstrates commitment to the development, implementation and effectiveness of
Quality Management System per ISO, FDA, and other regulatory agencies.
Responsible for exhibiting professional behavior with both internal/external business
associates that reflects positively on the company and is consistent with the company’s
policies and practices.
Understands and is aware of the quality consequences which may occur from the
improper performance of their specific job. Has awareness of device defects that may
occur in their area of responsibility, including product design, verification and
validation, manufacturing and testing activities.
Other duties as assigned, according to the changing needs of the business.
BASIC QUALIFICATIONS | EDUCATION:
Bachelor's Degree in Engineering, Chemistry, Biotechnology, Life Science or other
technical field or the equivalent combination of education and experience.
COMPETENCIES:
Working knowledge of Database software; Internet software; Inventory software;
Spreadsheet software and Word Processing software.
Working knowledge of FDA, cGMPs/QSR and ISO quality system requirements
Strong technical writing skills and effective communication skills
technical field or the equivalent combination of education and experience.
COMPETENCIES:
Working knowledge of Database software; Internet software; Inventory software;
Spreadsheet software and Word Processing software.
Working knowledge of FDA, cGMPs/QSR and ISO quality system requirements
Strong technical writing skills and effective communication skills