Analyst - quality assurance analyst - quality assurance

1 week ago

Madison WI, United States Indotronix Avani Group Full time

Summary The Senior Quality Analyst/Engineer is responsible for assuring that activities, processes, and product related to managing the processes of CAPA, Change Management, investigations, deviations, Quality Management Review, Audit coordination, and metrics for the Madison facility This position will have a wide range of tasks which may include Quality System improvement initiatives, data maintenance, trending and reporting, deviation investigation, internal/external auditing, and direct involvement and collaboration with the Regulatory Affairs, Operations, Technical Operations, Engineering, and Materials Management groups to drive quality culture.

Develop and maintain quality system processes, including metrics reporting and tracking
•Manage CAPA initiation, review, surveillance, and reporting
•Facilitate the site Quality Management reviews
•Facilitate and lead the site Change Management process
•Support and lead root cause analyses through cross-functional team involvement
•Leading Good Documentation Practice training and Quality on the Floor coordination and performance
•Interpret and properly apply all applicable regulatory requirements
•Coordinate and provide direct support for facility audits by internal and external entities
•Manage data collection and reporting when product recalls are required
•Perform trending of Quality Systems to support FDA and Management reviews
•Bachelor’s, or higher, degree in science/technology program preferred
•5+ years of Quality Assurance experience in a cGMP Quality Assurance/Compliant environment (medical devices preferred)
•Statistical analysis – Minitab or other software equivalent, preferred.

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