Quality Assurance Manager

hace 2 semanas


San Juan, San Juan, Puerto Rico MG STAFFING GROUP A tiempo completo
Job Description
MG STAFFING GROUP seeks a highly skilled Quality Assurance Manager to oversee the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and standards. The ideal candidate will provide expertise in interpreting policies, regulatory requirements, and agency guidelines to ensure compliance. Additionally, the Quality Assurance Manager will work directly with operating entities to provide process analyses oversight and lead audit and inspection preparation, resolution of audit and inspection findings, and liaise with auditing groups and inspectors. The Quality Assurance Manager will ensure the quality assurance programs and policies are maintained and modified regularly, facilitating uniform standards worldwide and enabling best practice sharing. The successful candidate will have a strong understanding of global regulatory requirements for medical devices, including FDA regulations, ISO 13485, Medical Device Directive, and European Medical Device Regulation. They will also possess experience in defining, driving, and implementing process improvement and functional excellence efforts. Key responsibilities include experience in Trackwise and MAP Agile tools, strong organizational skills, time management skills, ability to multitask, and prioritize. The Quality Assurance Manager will have the ability to work in a team environment as well as independently, with a continuous improvement mindset and high degree of initiative and good judgment.
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