Indotronix Avani Group · 1 day ago
Senior Quality Assurance Analyst
Madison, WI
Contract
Onsite
Senior Level
$50/hr - $50/hr
5+ years expIndotronix Avani Group is seeking a Senior Quality Assurance Analyst responsible for managing quality-related processes at their Madison facility. The role involves overseeing CAPA, Change Management, and conducting audits while collaborating with various departments to enhance the quality culture.
ConsultingMachine LearningSoftware
Hiring Manager
Mohammed Rizwan
Responsibilities
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
Review and approval of procedures, protocols, reports, etc., as required
Qualification
Required
Bachelor's, or higher, degree in science/technology program
5+ years of Quality Assurance experience in a cGMP Quality Assurance/Compliant environment (medical devices preferred)
Statistical analysis – Minitab or other software equivalent
Company
Indotronix Avani Group
Indotronix Avani Group is a consultancy that offers machine learning, cloud computing, software development and SaaS services.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Mitch Meller
Chief Operating Officer
Recent News
2023-12-25
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