Quality Engineer

Are you and experienced quality engineer who would like to work for a global supplier of medical devices that is just over an hour outside of Dallas TX and offers very competitive salary, benefits, bonus and relocation assistance if required.  Thispositionwillberesponsibleforthequalityprocessincludingcriticalprocesscharacteristics,standards, audits, complaint resolutions, training and laboratory functions related to FDA 21 CFR 820, FSSC22000, and ISO13485:2016.

§  Ensure integration of quality systems to ensure a common quality system throughout the facility and share best practices across the North American plant locations.

§  Provide manufacturing personnel with quality systems and tools to allow effective evaluation of products and processes.

§  Ensure the application of advanced quality tools to provide process improvement to the manufacturing group.

§  Ensure the quality management system meets the company’s medical device expectations and goals.

§  Formulate and maintain accurate documentation to meet all quality system and medical device expectations.

§  Lead and manage direct and indirect reports within the facility to meet or exceed targets for the medical device quality management system.

§  Maintain all aspects of the ISO 8 cleanroom including system validation and ongoing environmental monitoring.

§  Proactively review and improve quality systems and processes.

§  Investigatemoderatelycomplexmanufacturingproductqualityandcomplianceissues(e.g.CAPA,non-conformances, audit observations) in design and production processes prior to final product customer release. Make recommendations and confirm results.

§  Assistinthedevelopmentandinitiatestandardsandmethodsforinspection,testing,andevaluation,utilizing quality engineering analytical tools. Formulate quality assurance policies and procedures.

• Provides support to the manufacturing organization to ensure that Document Control is audit ready (internally and/or externally.) 
• Maintains document control systems, ensuring accuracy, organization, accessibility, and compliance with applicable standards.
• Manages Manufacturing MRP data and related databases, ensuring data accuracy, integrity, and timely updates.

This high-visibility position will report directly to the Quality Manager and will present the opportunity to work closely with manufacturing, customer service and other quality professionals to problem-solve and support new and existing projects.

·         Bachelor’sdegreerequired;preferableinanappropriatetechnicaldiscipline(Engineering,Math,&Science).

·         Atleasttwoyearsrelatedexperience;medicaldeviceexperiencehighly preferred.

·         Atleasttwoyears’experiencewithplasticmoldingequipmentandrotatingmachineryhighlypreferred.

If you meet the qualifications please apply.

Jason