Manufacturing Line Quality Engineer

Real Staffing Group; Scarborough (ME); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Health savings accounts

Retirement savings plan

Life and disability insurance

Paid leave

Job summary

Real Staffing Group in Scarborough, Maine, is seeking a Manufacturing Line Quality Engineer to support quality operations for diagnostic testing products, ensure product quality, resolve production issues, and drive process improvements across sites under the Scarborough Quality Management System.

You will partner with production teams to maintain compliance with FDA, cGMP/QSR, ISO, and QMS requirements, support inspections, reworks, and line clearances, and ensure accurate documentation.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Biotechnology, Life Sciences, or related field.
• Knowledge of FDA, cGMP/QSR, and ISO standards.
• Strong communication and technical writing skills.
• Proficiency with database, inventory, spreadsheet, internet, and word processing software.

Responsibilities

• Support manufacturing quality operations and resolve production issues.
• Drive process improvements across Scarborough sites.
• Maintain compliance with quality procedures and documentation.
• Support inspections, reworks, and line clearances.
• Promote adherence to FDA, cGMP/QSR, ISO and QMS requirements; contribute to CI initiatives.

Skills

Strong communication

Technical writing

Collaboration

Education

Bachelor's degree in Engineering, Chemistry, Biotechnology, Life Sciences, or related field

Tools

Database software

Inventory software

Spreadsheet (Excel)

Word processing (MS Word)

Job description

Manufacturing Line Quality Engineer

Support manufacturing quality operations for diagnostic testing products by ensuring product quality, resolving production issues, and driving process improvements across sites under the Scarborough Quality Management System. Partner with production teams to maintain compliance with quality procedures, support inspections, reworks, and line clearances, and ensure accurate documentation. Promote adherence to FDA, cGMP/QSR, ISO, and Quality Management System requirements while contributing to continuous improvement initiatives.

Requirements

Bachelor's degree in Engineering, Chemistry, Biotechnology, Life Sciences, or related field (or equivalent experience); knowledge of FDA, cGMP/QSR, and ISO standards; strong communication and technical writing skills; proficiency with database, inventory, spreadsheet, internet, and word processing software.

EOE Statement

Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.

To find out more about Real, please visit www.realstaffing.com