Manufacturing Line Quality Engineer

Lancesoft; Scarborough (ME); On-site; USD 65,000 - 90,000; Full time

Job summary

Lancesoft seeks a Manufacturing Line Quality Engineer in Scarborough, ME, supporting the Infectious Disease QA team. The role focuses on product quality assurance, process improvements, and quality system programs within the Scarborough QMS environment.

The position interacts with production on the floor, ensuring adherence to procedures and proper DHR documentation, including line clearances and inspections as required.

Qualifications

• Bachelor's Degree in Engineering, Chemistry, Biotechnology, Life Science or related field.
• Experience with FDA, ISO quality systems preferred.
• Strong technical writing and communication skills.

Responsibilities

• Support production on the manufacturing floor and resolve quality issues.
• Ensure proper DHR documentation and line clearances.
• Maintain compliance with FDA, cGMP/QSR, and ISO standards.

Education

Bachelor's Degree in Engineering, Chemistry, Biotechnology, Life Science

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