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Katalyst Healthcares & Life Sciences
QMS ConsultantKatalyst Healthcares & Life Sciences • Cincinnati, OH, United States
QMS Consultant

QMS Consultant

Katalyst Healthcares & Life Sciences • Cincinnati, OH, United States
30+ days ago
Job type
  • Full-time
Job description

QMS Consultant

We are seeking a QMS Consultant to support and maintain Quality Management System (QMS) processes for medical device projects in compliance with regulatory requirements. The ideal candidate will collaborate with cross-functional teams to ensure quality-compliant outcomes, support audits and inspections, manage risk and CAPA activities, and contribute to post-market surveillance and complaint handling initiatives. This is a long-term onsite contract opportunity in Blue Ash, OH with TCS.

Roles and Responsibilities:

  • Support and maintain Quality Management System (QMS) processes in compliance with applicable medical device regulations and standards.
  • Collaborate with cross-functional teams to ensure delivery of quality-compliant project outcomes.
  • Interpret and apply medical device regulations and industry standards to projects and operational processes.
  • Drive and support activities related to:
    • Complaint Handling
    • Post-Market Surveillance
    • Risk Management
    • Non-Conformance (NC)
    • Corrective and Preventive Actions (CAPA)
  • Perform and review risk assessments including FMEA and ISO 14971 activities.
  • Support internal and external audits and regulatory inspections, ensuring timely closure of audit findings and action items.
  • Manage quality deliverables across multiple projects while ensuring adherence to timelines and quality objectives.
  • Provide support for Ethicon-related project activities.

Education and Experience:

  • Bachelor's degree in Engineering, Life Sciences, Biomedical, Quality Management, or related field.
  • 46 years of experience in Quality Management Systems within the Medical Device industry.
  • Hands-on experience with Medical Device Regulations and Risk Management processes.
  • Experience with FMEA, ISO 14971, CAPA, NC, complaint handling, and post-market surveillance activities.
  • Strong understanding of regulatory compliance requirements and audit support processes.
  • Experience working in cross-functional and client-facing environments is preferred.
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QMS Consultant • Cincinnati, OH, United States

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