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Entry Level Manufacturing Line- Quality Engineer
Contract to Hire: Scarborough, Maine, US span>
Salary Range: 35.00 - 40.00 | Per Hour
Job Code: 372259
End Date: 2026-11-07
Days Left: 28 days, 5 hours left
Client: Medical
Duration: 3months (Possibilities of extension and conversions)
Schedule: Rotating 3rd shift, 6:00 PM–6:00 AM
Start: ASAPs
Manufacturing Line Quality Engineer supporting Clients Infectious Disease manufacturing operations. This role focuses on production quality, resolving manufacturing quality issues, maintaining DHR documentation, supporting inspections/reworks, and ensuring compliance with FDA, cGMP/QSR, and ISO quality requirements.
- Resolve quality issues on the manufacturing floor and support production.
- Ensure adherence to manufacturing procedures and accurate Device History Record (DHR) documentation.
- Support line clearances, reworks, inspections, and other quality activities.
- Support implementation and effectiveness of the Quality Management System (QMS).
- Ensure compliance with FDA, cGMP/QSR, ISO, and other applicable regulatory requirements.
- Identify and understand potential device/product defects across manufacturing and testing activities.
- Prepare technical documentation and communicate effectively with internal teams.
- Perform other quality/engineering duties as assigned.
- Bachelor's degree in Engineering, Chemistry, Biotechnology, Life Science, or another technical field, or equivalent experience.
- Experience with Quality Engineering / Manufacturing Quality / Quality Assurance.
- Working knowledge of:
- FDA regulations
- cGMP / QSR
- ISO Quality Systems
- Manufacturing quality processes
- DHR/documentation
- Strong technical writing and communication skills.
- Comfortable working directly on a manufacturing floor.
- C Flight: Sunday–Tuesday + alternating Wednesday, 6 PM–6 AM
-
D Flight: Thursday–Saturday + alternating Wednesday, 6 PM–6 AM
Pay range: $35 to $40 an hour
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.
Job Requirement
- Quality
- Engineer
- FDA
- cGMP
- QSR
- ISO
- DHR
- QMS
- documentation
Reach Out to a Recruiter
- Recruiter
- Phone
- Osama Patel Nur Mohammed
- nur.mohammed@collabera.com