Quality Engineer I - Medical Devices (Contract)

MillenniumSoft Inc; Durham (NC); On-site; USD 39,000 - 44,000; Full time

Job summary

MillenniumSoft Inc in Durham, NC is seeking a Quality Engineer I to support manufacturing operations through applying quality engineering principles, data analysis, and continuous improvement methodologies.

This role collaborates with Production, Manufacturing Engineering, Supply Chain, and Quality teams to improve product quality, reduce defects, investigate nonconformances, and ensure compliance with company quality standards and customer requirements.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering or related field
• 0-2 years of engineering, manufacturing, or quality experience
• Internship or co-op experience in a manufacturing environment preferred
• Understanding of quality engineering and manufacturing principles
• Knowledge of root cause analysis and problem-solving techniques
• Ability to analyze and interpret production and quality data
• Familiarity with quality tools such as Pareto Charts, Control Charts, Fishbone Diagrams, 5 Whys, FMEA
• Proficiency in Microsoft Excel, Power BI, and Microsoft Office applications
• Strong communication and teamwork skills
• Ability to work effectively in a fast-paced manufacturing environment
• Strong organizational and project management skills

Responsibilities

• Provide daily quality engineering support to manufacturing operations
• Monitor production processes to ensure compliance with established procedures and quality requirements
• Support containment, disposition, and resolution of nonconforming material
• Participate in Material Review Board (MRB) activities
• Partner with production personnel to identify and resolve quality issues impacting safety, quality, delivery, and productivity
• Investigate internal and customer-reported quality issues
• Perform root cause analysis using structured problem-solving methodologies
• Support the implementation and verification of corrective and preventive actions (CAPAs)
• Track assigned quality actions to timely completion
• Analyze quality data to identify trends, recurring defects, and improvement opportunities
• Support Lean Manufacturing and continuous improvement initiatives
• Assist with error-proofing (Poka-Yoke) and process control implementation
• Participate in Kaizen events and process improvement projects focused on reducing scrap, rework, and process variation
• Collect, analyze, and report quality performance metrics
• Prepare and present data-driven recommendations to management and cross-functional teams
• Ensure compliance with applicable quality procedures, standards, and work instructions
• Assist with the development and revision of quality documentation
• Support internal audits and corrective action activities
• Maintain accurate quality records and reports
• Participate in supplier quality investigations and corrective actions
• Support incoming inspection and supplier performance monitoring activities
• Assist with customer quality inquiries and complaint investigations as required

Skills

Quality engineering

Data analysis

Root cause analysis

Problem solving

Cross-functional collaboration

Education

Bachelor’s Degree in Mechanical or Electrical Engineering

Tools

Microsoft Excel

Power BI

Microsoft Office

Job description

MillenniumSoft Inc in Durham, NC is seeking a Quality Engineer I to support manufacturing operations through applying quality engineering principles, data analysis, and continuous improvement methodologies.

This role collaborates with Production, Manufacturing Engineering, Supply Chain, and Quality teams to improve product quality, reduce defects, investigate nonconformances, and ensure compliance with company quality standards and customer requirements.