Manufacturing Engineers – Drive Quality, Compliance & Innovation
Listed on 2026-09-06
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Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist, Production QC/QA, Quality Control - QC Analysts/Managers
Manufacturing Engineers – Drive Quality, Compliance & Innovation
Pay Rate: $44-$56/hr
Schedule:
Multiple shifts available (Day and Overnight Opportunities) Assignment Length:
Long-Term Contract Opportunities
We’re hiring experienced Manufacturing Engineers for multiple opportunities supporting our client, a leader in advanced manufacturing and life-changing health technology in Southern Maine. These positions offer competitive pay ranging from $44-$56/hr and are long‑term contract assignments anticipated to continue at least through 2026. This is an opportunity to join a high‑impact engineering team supporting quality, supplier quality, manufacturing automation, compliance, and continuous improvement initiatives in a highly regulated environment.
Ideal candidates enjoy solving complex manufacturing challenges, driving process improvements, supporting regulatory compliance, and collaborating across cross‑functional teams to deliver operational excellence.
- Support manufacturing process improvements, automation initiatives, and quality/cost savings projects
- Evaluate quality issues, non‑conformances, supplier performance, and manufacturing risks while identifying corrective actions
- Lead or participate in risk assessments, root cause investigations, FMEA activities, validation efforts, and compliance initiatives
- Develop, maintain, and revise quality and manufacturing documentation including SOPs, work instructions, protocols, specifications, and change controls
- Collaborate with Engineering, Quality, Manufacturing, Regulatory, and Supplier teams to ensure compliance and operational effectiveness
- Support audits, supplier qualification activities, process validation, testing, measurement, and continuous improvement efforts
- Analyze manufacturing and quality data to identify trends and drive decision‑making
- Ensure compliance with FDA, ISO, cGMP, ISO 13485, and other applicable regulatory requirements
- Bachelor’s degree in engineering or related technical discipline (or equivalent combination of education and experience)
- Experience in manufacturing, quality engineering, supplier quality, automation engineering, or related technical roles
- Strong analytical, troubleshooting, problem‑solving, and communication skills
- Experience working within regulated manufacturing environments and quality systems
- Familiarity with documentation control, change management, validation, risk assessment, or continuous improvement methodologies
- Proficiency with Microsoft Office applications and engineering‑related software tools
Preferred Qualifications :
- Experience with FDA, ISO, cGMP, GMP, ISO 13485, IVDR, IVD, or similar regulatory environments
- Knowledge of Lean Six Sigma, DMAIC, statistical analysis, Minitab, FMEA, DOE, CAPA, or root cause analysis methodologies
- Experience with automation systems, CAD software, supplier qualification, process validation, or manufacturing equipment improvement projects
- Familiarity with eQMS platforms such as Master Control, Track Wise, Agile, Veeva, ETQ, or similar systems
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