Overview

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

Type: Contract Job Title: Sterilization Quality Engineer 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 required; prefer program in Sciences or Engineering

Description Reporting directly to the division Sterilization Quality Engineer Lead, this role supports sterilization operations and the product sterility assurance program. The Sterilization Quality Engineer provides quality guidance for product and process sterility, decision-making for product resolution, and statistical problem-solving to support manufacturing operations and project teams. The position collaborates cross-functionally with Manufacturing, Laboratory, R&D, Quality Systems, Engineering, Procurement, and Marketing to ensure sterilization requirements meet regulatory, customer, and internal standards.

Requirements: • Interact with multiple functional groups within manufacturing and sterilization networks • Support product sterility assurance and compliance across multiple sites • Act as quality representative on various cross-functional projects • Coordinate and perform assigned projects; compile test data and generate reports • Provide validation support including planning, protocol development, execution (IQ/OQ/PQ), and change control • Lead/support activities related to changes impacting sterilization and associated functional testing • Facilitate and support investigations for product/process discrepancies and customer complaints • Support CAPAs with appropriate technical solutions • Create and maintain documentation in compliance with FDA and ISO requirements • Ensure compliance with regulatory standards for sterility assurance, including bioburden and sterility testing, dose audits, and environmental monitoring • Perform internal audits and support continuous improvement initiatives • React to changing priorities and perform other duties as needed

Required Qualifications

Education: • Bachelor’s Degree required; prefer program in Sciences or Engineering

Qualifications: • Minimum 2+ years of quality engineering experience in a regulated industry; medical device or pharmaceutical strongly • Direct experience in sterility assurance or product sterilization • Strong knowledge of 21 CFR Parts 820, 210/211, ISO 9001, ISO 13485, ISO 11137, ISO 11737 • Leadership experience managing cross-site projects in multifunctional teams • Proficiency in Microsoft Office Suite, Project, and Outlook • Technical writing skills and document control knowledge • Experience with sterilization processes highly desirable • Familiarity with Lean, Six Sigma, and validation methodologies • ASQ Certified Quality Engineer • Minitab proficiency desired • Ability to manage time independently and handle multiple priorities • Capable of making decisions regarding product disposition and CAPA effectiveness • Confident in providing direction to accomplish objectives

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 the requirements of all 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 Jamie.Robinson@ctg.com .