Indotronix Avani Group · 3 days ago
Senior Quality Engineer
Madison, WI
Contract
Onsite
Senior Level
$50/hr - $50/hr
5+ years expIndotronix Avani Group is seeking a Senior Quality Engineer to develop and maintain quality system processes and manage CAPA initiatives. The role involves leading quality management reviews, facilitating change management processes, and supporting root cause analyses while ensuring compliance with regulatory requirements.
ConsultingMachine LearningSoftware
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
Improve quality culture through site initiatives and improve existing procedures to better align with regulatory requirements
Review and approval of procedures, protocols, reports, etc., as required
Qualification
Required
5+ years of Quality Assurance experience in a cGMP Quality Assurance/Compliant environment (medical devices preferred)
Ability to utilize statistics at a moderate level for trending and interpretation of statistical data
Proficient with Microsoft Office tools, especially Excel, Word and PowerPoint
Technical writing
Preferred
Bachelor's, or higher, degree in science/technology program preferred
Statistical analysis – Minitab or other software equivalent, preferred
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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