Quality Assurance Specialist
On-siteMiamisburg, Ohio, United States
Job Summary
Develop and implement quality assurance procedures aligned with ISO 13485 standards while ensuring compliance with regulatory and customer requirements. Lead root cause analysis for customer complaints and corrective/preventive actions, perform internal audits, and support supplier and external audit activities. Analyze processes to identify risks, support First Article Inspection, and collaborate across Engineering, Operations, and Purchasing to drive continual improvement. Maintain the learning management system and develop work instructions to support process flow. This role requires three years of experience in medical devices, FDA, and ISO 13485, with proficiency in Document management systems and MS Office. Travel and flexible hours may be required to meet tight deadlines.
Required Qualifications
- At least three years' experience
- Ability to communicate verbally and in writing
- Computer intermediate or better proficiency
- Document management (PTC Windchill), MS Office desktop apps, SharePoint, Teams, server; CSI Syteline Enterprise Resource (ERP)/ Product Lifecycle Management (PLM)
- Must lift and/or move up to 35 pounds
- Specific vision abilities required by this job include close vision, depth vision, peripheral vision and the ability to adjust focus
- The postholder must be flexible in their approach, undertaking any other duties appropriate to the position, as necessary
- You may also be required to travel to locations other than your normal place of work
- Due to the nature of your role, it may be necessary to work to time constraints and tight deadlines
- This may occasionally require staying late or working outside normal working hours of attendance
Desired Qualifications
- Training or certifications desired: auditing, quality engineering, problem solving
- Experience in medical devices, FDA, and ISO 13485 is desired
- Ability to read mechanical drawings and interpret technical requirements is a plus
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