Manufacturing Line Quality Engineer

Duration: 03+ Months

First Shift: M-F 5:30am - 2pm

Second Shift: 2pm-1030pm

Description:

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.

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.

Preferred Qualifications:

None

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

Requirements

Basic Qualifications | Education:

• Bachelor's Degree in Engineering, Chemistry, Biotechnology, Life Science or other technical field or the equivalent combination of education and experience.

Preferred Qualifications:

None

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