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Quality Assurance Manager - Medical Device Manufacturing at Advanced Group in Long Island City, New York

Posted in Management 30+ days ago.





Job Description:


We are looking for a Quality Assurance Manager that has experience working in QA in a manufacturing environment for the medical device industries. This is a full-time, permanent opportunity and you will be working on site in Brooklyn, NY.


In this role you will be responsible for:


  • Manage all Quality System and Product Quality activities to ensure final product is safe and meets quality regulations

  • Design, implement and manage QMS

  • Determine root cause of any manufacturing issue and develop a solution

  • Ensure documentation is updated including SOP's, Manufacturing Batch Reports, Qualification and Validation and Test Reports

  • Involved in the compliance status of Change Control, Deviations, CAPA's, Investigations and Document Control System

  • Interact with senior leadership and cross-functional teams

  • Manage a small team of Quality Engineers

Qualifications:


  • 2+ years of QA Management experience in a manufacturing environment in a regulated industry such as medical device, aerospace or automotive

  • Background or experience with engineering is desired

  • Knowledge of Good Manufacturing Practices (GMP)

  • Knowledge of US Quality System Regulatory requirements

  • Strong knowledge of US regulations and communicating with regulatory agencies

  • Strong written and verbal communication skills, technical writing preferred

  • Bachelors Degree required, ASQ is a plus

If you are ready for your next challenge apply today!



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