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. Thispositionwillberesponsibleforthequalityprocessincludingcriticalprocesscharacteristicsstandards 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 companys 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.CAPAnon-conformances audit observations) in design and production processes prior to final product customer release. Make recommendations and confirm results.

Assistinthedevelopmentandinitiatestandardsandmethodsforinspectiontestingandevaluationutilizing 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.

Bachelorsdegreerequired;preferableinanappropriatetechnicaldiscipline(EngineeringMath&Science).

Atleasttwoyearsrelatedexperience;medicaldeviceexperiencehighlypreferred.

Atleasttwoyearsexperiencewithplasticmoldingequipmentandrotatingmachineryhighlypreferred.

If you meet the qualifications please apply.

Jason