Sterilization Quality Engineer Position Available In Durham, North Carolina
Tallo's Job Summary: CTG's Fortune 500 client is seeking a Sterilization Quality Engineer in Durham, NC. The role involves providing quality guidance for product and process sterility, collaborating cross-functionally, and ensuring compliance with regulatory standards. Requirements include a Bachelor's degree, 2+ years of quality engineering experience, and proficiency in relevant regulations and tools.
Job Description
CTG’s long-standing Fortune 500 client of over 15 years has a W2 contract assignment for a Sterilization Quality Engineer.
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Type:
- Contract
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Job Title:
- Sterilization Quality Engineer
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Location:
- Durham, NC _Candidates must be able to commute and work onsite in Durham, NC_
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Pay Rate:
- Based on experience
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Work Hours:
- M-F 8am-5pm
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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.
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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
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Education:
- Bachelor’s Degree required; prefer program in Sciences or Engineering
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Qualifications:
- Minimum 2+ years of quality engineering experience in a regulated industry; medical device or pharmaceutical strongly preferred
- Direct experience in sterility assurance or product sterilization preferred
- 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 preferred
- 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
Over nearly 60 years, we have earned a reputation as a faster and more reliable, results-driven partner. Our vision is to be an indispensable partner to our clients and the preferred career destination for digital and technology experts. CTG leverages the expertise of over 9,000 team members in 19 countries to provide innovative solutions. Together, we operate across the Americas, Europe, and India, working in close cooperation with over 3,000 clients in many of today’s highest-growth industries. For more information, visit www.ctg.com . Our culture is a direct result of the people who work at CTG, the values we hold, and the actions we take. In other words, our people define our culture. It’s a living, breathing thing that is renewed every day through the ways we engage with each other, our clients, and our communities. Part of our mission is to cultivate a workplace that attracts and develops the best people, reflected by our recognition as a Great Place to Work Certified™ company across many of our global operations. CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws. CTG is an Equal Opportunity Employer. CTG will assure equal opportunity and consideration to all applicants and employees in recruitment, selection, placement, training, benefits, compensation, promotion, transfer, and release of individuals without regard to race, creed, religion, color, national origin, sex, sexual orientation, gender identity and gender expression, age, disability, marital or veteran status, citizenship status, or any other discriminatory factors as required by law. CTG is fully committed to promoting employment opportunities for members of protected classes.
