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Quality System Specialist

  • Ref: 291338
  • Type: Direct Hire
  • Location: Lexington, MA
  • Industry: Medical Devices
  • Job Level: Experienced Non-Manager
  • Pay: Negotiable

Opportunity Description

The position of Quality Specialist supports full, 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.

Job Duties

  • 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
  • Other duties as assigned 

Education

  • Bachelor Degree highly preferred

Experience & Skills Required

  • Three (3) or more years of hands-on experience performing Quality System support activities in a U.S. FDA regulated the 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)
  • Excellent leadership, communication, collaboration, teamwork, and interpersonal skills
  • Superb ability to effectively communicate with staff members and business partners at all levels of the organization (both internal and external)
  • Excellent computer and internet search skills
  • Strong ability to multi-task and to meet business deadlines
  • Excellent organizational skills with an ability to think proactively and prioritize work