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Job #02637

About our client Our client is a rapidly growing medical device company headquartered in Gainesville, Florida that is focused on improving nerve repair and regeneration. The company has a rich pipeline of products to change the standard of care for patients with nerve damage. Position Location Quality Specialist Gainesville, Florida Salary Reports to Highly competitive package, commensurate with experience Management Responsibilities 1) Support Operations by providing process-improvement initiatives, process auditing and supplier quality activities 2) Provide guidance and perform (direct) product review activities, product audits and calibration 3) Establish and promote a professional working relationship with both internal and external associates, and customers, in the development of quality plans, procedures and test methods 4) Develop quality metrics 5) Provide leadership to Material Review Board and CAPAs 6) Support routine histology, environmental monitoring, sterility and other quality monitoring activities 7) Interpret and apply sampling plans and statistical techniques 8) Develop, review and approve work instructions, material specifications and associated engineering drawings for all of operations 9) Support process qualification/validation (test/equipment) 10) Lead compliance of engineering specifications to SOP, work instructions 11) Support customer quality issues 12) Train new and existing employees in cGMPs, cGTP and QA procedures 13) Support CAR process 14) Work continuously with Operations to improve yields, efficiencies, product quality and minimize product waste 15) Perform other tasks as assigned Requirements 1) B.S in a scientific discipline 2) 3 years of professional experience 3) Working knowledge of Lean/Progressive Manufacturing and quality disciplines ASQ CQE 4) Ability to work in a team environment 5) Willingness to process and handle animal and human tissue 6) Passionate about work and results-driven 7) Customer-centric individual 8) Demonstrated ability to respect others and show consideration 9) Willingness to travel – up to 50%