Quality Engineer I

Overview

CTG's long-standing Fortune 500 client of over 15 years has a W2 contract assignment for a Quality Engineer.

Type: Contract
Job Title: Quality Engineer I
Location: Durham, NC
Candidates must be able to commute and work onsite in Durham, NC
Pay Rate: Based on experience
Work Hours: M–F 8am–5pm
Education: Bachelor’s Degree in Engineering

Description
CTG is seeking a Quality Engineer I to support a manufacturing environment for a well-established client in Corning, NY. Reporting directly to the Quality Engineering Supervisor, this role involves supporting product teams in manufacturing operations with quality guidance, resolution decisions, and statistical problem-solving for process improvements, new product introductions, validations, and continuous improvement initiatives. This position collaborates closely with cross-functional teams to ensure the quality of products and processes for assigned product lines.

Requirements:

• Support product teams with MRB, customer complaint resolution, statistical analysis, inspection planning, metrology, and quality metrics

• Act as the point of contact for the Quality Help Desk and manage customer complaint activities including questionnaires, certificates, and surveys

• Facilitate and document investigations such as Nonconforming Process Reports (NCPR), Situation Analysis (SA), and Health Hazard Evaluations (HHE)

• Lead discussions in Material Review Board (MRB) meetings regarding blocked stock and open notifications

• Investigate and resolve Corrective & Preventive Actions (CAPA), non-conforming products, and customer complaints

• Apply quality engineering methodologies including Six Sigma, FMEA, DOE, MSA, and validation protocols

• Support key plant projects and continuous improvement initiatives

• Develop and revise Quality Plans (incoming, in-process, and final inspections) and train relevant personnel

• Implement and train on inspection and metrology improvements

• Review and approve Project Design History Files

• Author technical process documents compliant with FDA and ISO standards

• Conduct internal audits to ensure quality system compliance

• Perform additional duties as assigned and adapt to changing business needs

Required Qualifications

Education:

• Bachelor’s Degree in Engineering

Experience:

• Minimum of 2 years of quality engineering experience in a manufacturing environment

• Experience in regulated industries such as healthcare, medical devices, or pharmaceuticals preferred

Qualifications

• Knowledge of Continuous Improvement methodologies such as Lean and Six Sigma

• Strong decision-making, time management, and prioritization skills

• Familiarity with statistical tools and methods used in quality assurance

• Understanding of quality regulations and standards (ISO13485, ISO15378, 21 CFR Part 820, GDP/cGMP)

• Proficient in Minitab, Microsoft Office Suite (Excel, Project, Word), SAP, EtQ, and databases

• Technical writing and documentation skills

• ASQ Certifications (CQE, CQA) preferred

Additional Information

• No third party resumes will be accepted

• Drug testing and/or other employment-related inquiries may be conducted

• CTG will consider for employment-qualified applicants with criminal histories in a manner consistent with applicable local, state, and federal laws

• All interested individuals MUST be able to work on a W2 Tax basis (no C2C or third-party vendors)

• CTG is an Equal Employment Opportunity employer

• CTG is an E-Verify Company

To be considered for this opportunity, please apply directly through our website or email your Word version resume and salary expectations to Jeffrey.Thompson@ctg.com.