Overview
Quality Engineer Jobs in Durham, NC at RevereIT LLC
Title: Quality Engineer
Company: RevereIT LLC
Location: Durham, NC
Title: Quality Engineer
Location: Durham, NC
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Mentor and coach junior Quality Engineers in NPI and commercial areas.
• Establish and deliver training programs on QE principles, cGMPs, product, and process familiarity.
• Collaborate with engineering, business development, and cross-functional teams in development, manufacturing, and procurement.
• Ensure high standards of work, effective time management, and data-driven problem-solving.
• Present quality standards, process flows, and inspection plans confidently and accurately, both internally and externally.
Technical (Product and Process)
• Lead new customer programs through the development lifecycle, promoting best engineering practices.
• Develop and implement workflows and sampling plans for OQ/PQ activities.
• Analyze manufacturing data, conduct root cause analysis of deviations/complaints, and support design/manufacturing concept selection.
• Create and maintain work standards to ensure projects are delivered on time, within scope, and budget.
• Interpret product requirements and ensure compliance with quality system procedures and industry standards.
• Develop Master Batch Records, work instructions, and related manufacturing and packaging documentation.
• Support the generation of Measurement System Analysis, Control Plans, Process Flow Maps, Inspection plans, GR&R, and test requirements.
• Maintain process discipline to meet project deliverables, including manufacturing strategy, capability analysis, FMEA, tooling selection, risk management, cost modeling, Design for Manufacturing, and process validation.
• Review and develop technical specifications and use data-driven tools for problem-solving.
• Identify opportunities for product and process improvements and develop recommendations.
QUALIFICATIONS
Required:
• College Degree required (engineering degree or related scientific degree). Must have a minimum of at least five years of experience in an FDA regulated industry with strong preference to medical device or
combination products.
• Demonstrated proficiency with personal computers, business software (e.g., MS Office) and technical
software (ERP and eQMS systems). Ability to create, use and interpret scientific tables, charts, and graphs.
• Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various
computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels
pertinent to professional needs.
• Analytical ability to drive effective Root Cause Analysis (RCA) and critical thinking for complex problem
