Quality Engineer I
Location: Durham
Posted on: June 23, 2025
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Job Description:
DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology
and Talent solutions firm. Driven by a unique Purpose, Culture, and
Value Delivery Model, we enable meaningful connections between
talented professionals and forward-thinking organizations. Since
our formation in 2002, organizations across commercial and public
sectors have been trusting us to help build their teams with
exceptional temporary and permanent talent. Visit us at
https://divihn.com/find-a-job/ to learn more and view our open
positions. Please apply or call one of us to learn more For further
inquiries regarding the following opportunity, please contact our
Talent Specialist: Hema at 630 847-0275 Title: Quality Engineer I
Location: Durham, NC Duration: 12 Months Description: Reporting
directly to the division Sterilization Quality Engineer Lead, this
position involves support for the sterilization operations and
product sterility assurance program. This position provides quality
guidance for product and process sterility, product resolution
decisions, and statistical problem-solving techniques to
manufacturing operations and project teams for new product
introduction, process improvements, continuous improvements, and
validation activities. This position works closely with other
functions within the organization (Manufacturing, Laboratory,
RandD, Quality Systems, Engineering, Procurement and Marketing) and
is responsible for ensuring the sterilization requirements are met
for product sterilized to ensure compliance to regulatory, customer
and internal standards. Description of Work: This position
interacts with multiple functional groups within manufacturing and
sterilization networks. Supports product sterility assurance and
compliance across multiple sites within the Life Sciences division.
Serves as the quality representative to support multiple projects
within the division. Schedules/coordinates/performs assigned
projects, compiles test data, writes summary reports and final
reports. Provides validation support including master validation
planning, change controls, protocol development, review and
approvals, IQ/OQ/PQ execution/support, assist with FMEAs and
control plans, assist with documentation in electronic document
management system. Lead and support activities related to product
changes impacting sterilization equipment/processes and the
associated laboratory/functional testing required as part of the
validations. Facilitate/support investigations for product and
process discrepancies and propose corrective actions to process
deviations and customer complaints. Assist with the investigation
of Corrective and Preventive Actions (CAPA), providing solutions
where possible. Create or modify user documentations that fit the
business needs and maintain compliance to the regulatory
requirements of the FDA and ISO standards. Ensures compliance to
regulatory requirements related to product sterility assurance
including annual product reviews, environmental controls, bioburden
testing, dose audit maintenance and sterility testing. Serve as a
resource for performing internal audits to ensure quality system
compliance. Drive improvements to deliver on key quality goals and
metrics. Able to react to change and perform other duties as
assigned. Qualification: Bachelor's Degree required, prefer program
in Sciences or Engineering. Minimum of 2 years of quality
engineering experience in a highly regulated industry; strongly
prefer medical device or pharmaceutical. Direct experience in
sterility assurance or product sterilization a plus.
Skills/Experience: Strong knowledge of the regulatory and quality
system requirements 21 CFR Parts 820, 210/211, ISO 9001, ISO 13485,
ISO 11137 and ISO 11737. Leadership ability to coordinate projects
at multiple locations in a multi-functional team environment.
Working knowledge of databases and spreadsheet applications to
perform necessary tasks for preparing required data analysis,
reports, documents and general communication. Knowledge of
manufacturing processes and relevant statistical methods for
quality assurance. Good understanding of continuous improvement
methodologies, including lean, six sigma, statistical applications
and validation. Must have proficiency using Microsoft Office,
Project, Outlook, and software applications. Demonstrated technical
writing skills. Experience with sterilization processes highly
preferred. ASQ Certified Quality Engineer desired. Minitab software
proficiency, desired. Ability to work independently with strong
time management and prioritization skills to handle multiple
assignments and interact with project teams. Ability to make
decisions regarding product disposition and corrective and
preventive action effectiveness. Comfortable in giving direction to
accomplish work being executed Manufacturing experience/knowledge,
GDP and GMP familiarity, Word and Excel experience preferred as
well as documentation experience Manager will have 1 phone screen
and 1 onsite panel interview with candidates. About us: DivIHN ,
the 'IT Asset Performance Services' organization, provides
Professional Consulting, Custom Projects, and Professional Resource
Augmentation services to clients in the Mid-West and beyond. The
strategic characteristics of the organization are Standardization,
Specialization, and Collaboration. DivIHN is an equal opportunity
employer. DivIHN does not and shall not discriminate against any
employee or qualified applicant on the basis of race, color,
religion (creed), gender, gender expression, age, national origin
(ancestry), disability, marital status, sexual orientation, or
military status.
Keywords: , Greensboro , Quality Engineer I, Engineering , Durham, North Carolina
