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Job #03623

About our client Our client is a publicly traded medical device company that is focused on the development and distribution of innovative products for the dental market. They boast exceptional revenue growth, an experienced management team and clear leadership positions in their core segments. This is a unique opportunity for someone that wants to put their drive and initiative to work! Position Location Quality Engineer Oklahoma Salary Highly competitive package, commensurate with experience Responsibilities 1) Follow quality assurance and product development guidelines and procedures 2) Ensure that developed and marketed products comply with quality, regulatory, and engineering requirements 3) Provide quality engineering support to the Product Development Team 4) Work closely with R&D, Marketing and Operations to develop and implement appropriate risk management, qualification, verification and validation plans 5) Review and approve documents that support product development activities, including design input/output, verification, validation, traceability analysis, risk analysis, packaging protocols and reports 6) Participate in design, phase and stage gate reviews to support assigned development projects as well as ensure all generated documentation is complete 7) Provide guidance in the early selection and assessment of suppliers 8) Lead problem-solving efforts to identify and resolve new and recurring quality issues 9) Ensure development and production of safe and effective medical devices 10) Prepare and review qualification and validation test plans, reports for assigned projects, including, if required, reliability assessment 11) Ensure the resolution of issues raised by testing 12) Develop, implement, manage and track effectiveness of corrective action plans and compliance improvement initiatives 13) Ensure accurate project schedules are maintained and communicated to both internal and external management 14) Perform statistical analysis of data and writes technical reports Requirements 1) BS in Science, Engineering or a related discipline 2) ASQ certification as CQA, CQE or CRE 3) 5 – 10 years of experience as a Quality Engineer in the medical device or comparable regulated industry 4) Working knowledge of product development life cycle from feasibility through product retirement including design verification and validation, product release, configuration management, risk management, reliability testing and post market surveillance 5) Working knowledge of GMP, quality systems, regulatory requirements, design validation principles and manufacturing methods in Medical Device regulated environment 6) General knowledge of FDA 21 CFR 820 Quality System Regulation, ISO 13485 2003, Medical Device Directive 93/42/EEC, ISO 14971 2007 7) Knowledge of policies and procedures involved in managing an organization’s risk exposures 8) Strong project management skills 9) Strong mathematical, statistical and mechanical aptitude skills 10) Effective communication skills through reading, writing and verbal media 11) Strong computer skills – Microsoft Office suite 12) Ability to multi-task and work without direct supervision 13) Ability to analyze, estimate and evaluate