Manufacturing Line Quality Engineer

Spectraforce Technologies, Inc.; Scarborough (ME); On-site; USD 39,000 - 61,000; Part time

Job summary

Spectraforce Technologies, Inc. is hiring a Manufacturing Line Quality Engineer for an onsite, 3-month assignment in Scarborough, Maine (04074).

The role focuses on supporting production to resolve quality issues, maintaining device history records, and ensuring compliance with ISO, FDA, and other quality standards. Qualifications include a Bachelor's degree in engineering or related technical field and working knowledge of database, spreadsheet, and word processing software, plus familiarity

Qualifications

• Bachelor's degree in a technical field or equivalent experience.
• Familiarity with FDA, cGMPs/QSR and ISO quality systems.
• Strong writing and communication skills.

Responsibilities

• Support production in resolving quality issues per procedures.
• Maintain DHR documentation and assist line clearances, reworks, inspections.
• Commit to Quality Management System compliance including ISO and FDA standards.

Skills

Technical writing

Effective communication

Education

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

Tools

Database software

Internet software

Inventory software

Spreadsheet software

Word processing software

FDA, cGMPs/QSR, ISO quality systems

Job description

Position Title: Manufacturing Line Quality Engineer

Work Location: Scarborough, Maine, 04074

Work Arrangement: Onsite

Duration: 3-month assignment

Work Schedule: Rotating 3rd Shift

Shift Flights

• C Flight: Sunday-Tuesday, plus alternating Wednesdays
  Hours: 6:00 PM-6:00 AM
• D Flight: Thursday-Saturday, plus alternating Wednesdays
  Hours: 6:00 PM-6:00 AM

Important

Candidates must be generally available to work either the C Flight or D Flight.

Position Summary

Our organization is part of The Organization's Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

Background & Context

This job description will be reviewed periodically and is subject to change by management.

Key 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.

Qualification & Experience

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

Additional Information

An equal opportunity employer, The Organization welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities.