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Collabera · Scarborough, Maine
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Entry Level Manufacturing Line- Quality Engineer Contract to Hire: Scarborough, Maine, US Salary Range: 35.00 - 40.00 | Per Hour Job Code: 372259 End Date: 2026-11-07 Days Left: 10 days, 3 hours left Apply Quality Engineer - Manufacturing Line Quality Engineer
Scarborough, ME 04074 Client: Medical Duration: 3months (Possibilities of extension and conversions) Schedule: Rotating 3rd shift, 6:00 PM-6:00 AM Start: ASAPs Reloaction candidates can also applyJob Summary: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. Key Responsibilities
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. Required
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. Important Shift RequirementThis is not a standard Monday-Friday schedule. Candidates must be generally available for either rotating 3rd-shift flight: 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 Email Phone Osama Patel Nur Mohammed nur.mohammed@collabera.com
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Details
| Company | Collabera |
| Location | Scarborough, Maine |
| Type | FULL TIME |
| Niche | Architecture and Engineering Occupations |