Quality Engineer I Position Available In Durham, North Carolina

Job Description:

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technologyand Talent solutions firm. Driven by a unique Purpose, Culture, andValue Delivery Model, we enable meaningful connections betweentalented professionals and forward-thinking organizations. Sinceour formation in 2002, organizations across commercial and publicsectors have been trusting us to help build their teams withexceptional temporary and permanent talent.

Visit us athttps:

//divihn.com/find-a-job/ to learn more and view our openpositions. Please apply or call one of us to learn more For furtherinquiries regarding the following opportunity, please contact our

Talent Specialist:

Hema at 630 847-0275

Title:

Quality Engineer ILocation:

Durham, NC Duration:

12

Months Description:

Reportingdirectly to the division Sterilization Quality Engineer Lead, thisposition involves support for the sterilization operations andproduct sterility assurance program. This position provides qualityguidance for product and process sterility, product resolutiondecisions, and statistical problem-solving techniques tomanufacturing operations and project teams for new productintroduction, process improvements, continuous improvements, andvalidation activities. This position works closely with otherfunctions within the organization (Manufacturing, Laboratory,RandD, Quality Systems, Engineering, Procurement and Marketing) andis responsible for ensuring the sterilization requirements are metfor product sterilized to ensure compliance to regulatory, customerand internal standards.

Description of Work:

This positioninteracts with multiple functional groups within manufacturing andsterilization networks. Supports product sterility assurance andcompliance across multiple sites within the Life Sciences division.

Serves as the quality representative to support multiple projectswithin the division. Schedules/coordinates/performs assignedprojects, compiles test data, writes summary reports and finalreports. Provides validation support including master validationplanning, change controls, protocol development, review andapprovals, IQ/OQ/PQ execution/support, assist with FMEAs andcontrol plans, assist with documentation in electronic documentmanagement system. Lead and support activities related to productchanges impacting sterilization equipment/processes and theassociated laboratory/functional testing required as part of thevalidations. Facilitate/support investigations for product andprocess discrepancies and propose corrective actions to processdeviations and customer complaints. Assist with the investigationof Corrective and Preventive Actions (CAPA), providing solutionswhere possible. Create or modify user documentations that fit thebusiness needs and maintain compliance to the regulatoryrequirements of the FDA and ISO standards. Ensures compliance toregulatory requirements related to product sterility assuranceincluding annual product reviews, environmental controls, bioburdentesting, dose audit maintenance and sterility testing. Serve as aresource for performing internal audits to ensure quality systemcompliance. Drive improvements to deliver on key quality goals andmetrics. Able to react to change and perform other duties asassigned.

Qualification:

Bachelor’s Degree required, prefer programin Sciences or Engineering. Minimum of 2 years of qualityengineering experience in a highly regulated industry; stronglyprefer medical device or pharmaceutical. Direct experience insterility assurance or product sterilization a plus.

Skills/Experience:

Strong knowledge of the regulatory and qualitysystem requirements 21 CFR Parts 820, 210/211, ISO 9001, ISO 13485,ISO 11137 and

ISO 11737.

Leadership ability to coordinate projectsat multiple locations in a multi-functional team environment.

Working knowledge of databases and spreadsheet applications toperform necessary tasks for preparing required data analysis,reports, documents and general communication. Knowledge ofmanufacturing processes and relevant statistical methods forquality assurance. Good understanding of continuous improvementmethodologies, including lean, six sigma, statistical applicationsand validation. Must have proficiency using Microsoft Office,Project, Outlook, and software applications. Demonstrated technicalwriting skills. Experience with sterilization processes highlypreferred. ASQ Certified Quality Engineer desired. Minitab softwareproficiency, desired. Ability to work independently with strongtime management and prioritization skills to handle multipleassignments and interact with project teams. Ability to makedecisions regarding product disposition and corrective andpreventive action effectiveness. Comfortable in giving direction toaccomplish work being executed Manufacturing experience/knowledge,GDP and GMP familiarity, Word and Excel experience preferred aswell as documentation experience Manager will have 1 phone screenand 1 onsite panel interview with candidates.

About us:

DivIHN ,the ‘IT Asset Performance Services’ organization, providesProfessional Consulting, Custom Projects, and Professional ResourceAugmentation services to clients in the Mid-West and beyond. Thestrategic characteristics of the organization are Standardization,Specialization, and Collaboration. DivIHN is an equal opportunityemployer. DivIHN does not and shall not discriminate against anyemployee or qualified applicant on the basis of race, color,religion (creed), gender, gender expression, age, national origin(ancestry), disability, marital status, sexual orientation, ormilitary status.