Position : Quality Engineer I

Location : Durham, NC

Duration : 12 Months

1^st Shift

Total Hours/week : 40.00

Client : Medical Devices Company

Job Category : Engineering

Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT

Pay rate:$30/hr

JOB DESCRIPTION

• Quality Engineer I is responsible for supporting manufacturing operations through the application of quality engineering principles, data analysis, and continuous improvement methodologies.
• This role works closely 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.

• The Quality Engineer I supports day-to-day manufacturing quality activities, including nonconformance management, root cause investigations, corrective actions, process monitoring, and quality metric reporting.

Key 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 and Experience

• 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.

Bonus Skills

• ISO 9001 Quality Management Systems
• Statistical Process Control (SPC)
• Lean Manufacturing
• Six Sigma methodologies
• Experience with ERP and quality management systems.
• ASQ certification or willingness to pursue certification.

Working Conditions and physical demands

• Combination of office and manufacturing floor environment.
• Frequent interaction with production employees and cross-functional teams.
• Ability to work in a manufacturing setting and wear required PPE.
• Occasional travel may be required for supplier visits, training, or project support.

• Must be able to carry, lift and push/pull up to 30 pounds frequently and up to 50 pounds occasionally.
• Must have the ability to see, smell, hear, talk, climb, balance, stoop, kneel and twist, crouch, crawl, reach, grasp, sit, stand, and walk.
• Weekend and overtime work may be required.
• Travel by car and/or air is required. Travel of 10% should be expected.
• Additional physical duties may be required as necessary.