Summary:

Are you passionate about quality, compliance, and helping bring innovative medical devices to market A local manufacturer is seeking a Quality Manager to develop and lead their Quality department and ensure compliance with FDA and ISO standards. This is a Direct Hire position with 1st shift schedule. Pay consideration starts at $35/hr (higher rates based on experience) plus benefits. This is an exciting opportunity for a hands-on quality professional who enjoys building scalable systems, working independently, and making a meaningful impact within a growing medical device organization. Don't miss out on this opportunity at a growing company. Apply today to be considered! Responsibilities Implement, maintain and continuously improve the QMS Create, review and approve quality system documents Establish and maintain supplier qualifications, evaluations and monitoring Develop and execute process validation activities Lead CAPA and Root Cuse investigations Establish and maintain internal audit program and schedule Qualifications Bachelor's degree in Engineering, Life Sciences or related scientific discipline Previous hands-on quality experience in medical device industry Experience with supplier quality, validation, CAPA, complaints and post market processes Knowledge of FDA QMSR and

ISO 13485

Strong documentation and communication skills #indMMIS