Quality System Specialist

Direct Hire

The quality system specialist will support Quality Systems to ensure ongoing compliance to all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations and standards.

Role and Primary Responsibilities:

• Evaluate all sources of incoming customer information, identify, investigate and document Customer Complaints, perform trend analysis and maintain all records
• Determine the Medical Device Reportability of all identified Customer Complaints, take appropriate action and maintain all records
• Coordinate all Mandatory Field Notifications and Engineering Change Orders, take appropriate action and maintain all records
• Interact closely with Customer Service, Service, Repair, Research and Development, Quality Assurance, Regulatory Affairs and Sales to facilitate required action
• Perform Corrective and Preventive Action and Nonconforming Product activities
• Perform Internal Audits and External Supplier Audits
• Coordinate U.S. FDA remediation activities
• Prepare Management Review Meeting presentations
• Comply with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations and standards
• Attend all department and company-wide team meetings as needed

Minimum Requirements:

• Bachelor Degree highly preferred
• Three (3) or more years of hands on experience performing Quality System support activities in a U.S. FDA regulated environment
• Deep knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807)
• Deep knowledge of international medical device standard requirements (ISO 13485/ISO 9001, ISO 14971, EU Medical Device Directive and Canada Medical Device Regulations)