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jobs description

Purpose: The Quality Assurance Manager ensures regulatory compliance, best-in-class quality practices, and supports growth. This role manages cGMP manufacturing, packaging, testing, and storage activities and participates in relevant audits. Collaborates with various departments to maintain an organized, efficient, and compliant quality management system (QMS) in line with FDA requirements.

Key... Responsibilities:
• Ensure high-quality, safe, and legally compliant product production.
• Stay current with regulations and ensure readiness for FDA audits.
• Maintain ISO 13485 certification and GMP compliant document control.
• Oversee customer complaints, CAPA, and qualification of suppliers.
• Manage multiple projects and rapidly learn new systems.
• Lead change and resolve quality issues collaboratively with production.
• Interface with customers on quality-related requests and issues.
• Oversee documentation management and in-process product inspection standards.
• Partner with cross-functional teams to ensure compliance with quality standards.
• Analyze production data to identify trends and drive continuous improvement.
• Report on KPIs and support internal and external audits.

• 10+ years of Quality Assurance experience, preferably in medical devices.
• B.S. in sciences, engineering, or technical fields.
• Direct manufacturing experience.
• Strong knowledge of quality systems and regulatory compliance (FDA, ISO).
• Exceptional communication skills and high-quality standards.
• Proficiency in MS Office; preferred knowledge of statistical software (Minitab), ERP, and digital quality management software.
• Ability to travel domestically and internationally (25%).
• Preferred certifications: CQA, CQE, CQM
Indianapolis IN USA


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