Quality Engineer

LanceSoft, Inc.; Scarborough (ME); On-site; USD 70,000 - 95,000; Full time

Job summary

LanceSoft, Inc. in Scarborough, ME is seeking a Manufacturing Line Quality Engineer for the Infectious Disease division. You will support product quality assurance, process improvements, and quality system programs on the production floor.

This contract role runs from 11/02/2026 to 01/31/2027 with rotating 3rd shift (C and D flights) and requires a bachelor's degree in a technical field and knowledge of FDA/cGMP/ISO guidelines. You will resolve quality issues and maintain DHR documentation.

Qualifications

• Bachelor's Degree in Engineering, Chemistry, Biotechnology, Life Science or other technical field or the equivalent combination of education and experience.
• Demonstrated ability in technical writing and clear communication, and knowledge of FDA, cGMPs/QSR and ISO quality system requirements.

Responsibilities

• Support production with resolution of quality issues in accordance with established procedures.
• Support production on the manufacturing floor, ensuring adherence to procedures and DHR documentation; supports line clearances, reworks, and inspections.
• Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
• Exhibits professional behavior with internal/external business associates reflecting company policies and practices.
• Understands quality consequences from improper performance and is aware of device defects in their area of responsibility.
• Other duties as assigned, according to changing business needs.

Skills

Technical writing

Communication

Quality systems knowledge

Education

Bachelor's Degree in Engineering or other technical field

Tools

Database software

Internet software

Inventory software

Spreadsheet software

Word processing software

Job description

Title: Manufacturing Line Quality Engineer

Location: Scarborough, ME – 04074

Duration: 11/02/2026 to 01/31/2027

Location: Scarborough This is for a rotating 3rd shift schedule: C flight would be Sunday-Tuesday with alternating Wednesday. 18:00-06:00 D flight would be Thursday-Saturday with alternating Wednesday. 18:00-06:00

The position of Manufacturing Line Quality Engineer is within our Infectious Disease business unit located at all sites under Client Diagnostics Scarborough QMS. In this role you will provide support for product quality assurance, process improvements, and all quality system programs. 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