Quality Manager
On-site · Columbus, Ohio, United States
Job Summary
Quality Manager to develop and enforce quality standards across departments, analyze data to drive improvements, and ensure compliance with ISO and FDA-regulated requirements. Responsibilities include implementing inspection/evaluation methods, preparing reports on inspections/receiving, reporting quality issues to upper management, supervising staff to maintain standards, maintaining a Quality Management System and staying current with industry standards, conducting training and qualification programs, managing product recall data and communicating recalls to management/customers, maintaining a photo library of inbound products, presenting a Quality Management System for audits by customers and certification authorities. Required experience with ISO 9001:2015, FDA-regulated environments, and auditing, plus strong data analysis, communication, and MS Office skills. BS in related field or 2+ years in quality programs; location is Columbus, OH, USA; role appears on-site.
Required Qualifications
- BS in Quality Standards or related field or 2+ years experience running a quality program
- Experience in Medical Device or other FDA-regulated industry MUST
- Experience with ISO 9001:2015
- Hands-on experience inspecting incoming medical products
- Experience auditing and presenting records for audit by external organizations
- Excellent verbal and written communication
- Data analysis and statistical aptitude
- Microsoft Office: Excel, Word, PowerPoint
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