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Quality Assurance Manager

1 month ago

Lincolnshire, Kentucky, United States Sysmex America Full time

At Sysmex America, we are seeking a highly skilled Quality Assurance Manager to oversee and manage the quality of product and process at our facility. The successful candidate will ensure that quality management systems processes are adhered to in accordance with established Good Manufacturing Practices (GMP), ISO, and applicable regulatory requirements.

The Quality Assurance Manager will be responsible for ensuring the accurate and timely completion of Quality Management System documents, including CAPAs, Non-Conformances, Deviations, and other processes measured in accordance with Quality Objectives and Key Performance Indicators. This role will also lead a team of Quality professionals responsible for monitoring day-to-day business activities, including review and approval of medical devices for product release.

The ideal candidate will have a Bachelor's degree in a related field and 5-8 years of experience in QA in a related industry. Knowledge of cGMP (FDA QSR) and ISO 13485 regulations is required, and ASQ or other industry certifications are a plus. Strong analytical skills, verbal and written communication skills, and proficiency in Microsoft Office Suite are also essential.

This is a great opportunity for a motivated and detail-oriented individual to join our team and contribute to the success of Sysmex America.