QMS Consultant

Job Summary:

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 & 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 & Experience:

• Bachelor's degree in Engineering, Life Sciences, Biomedical, Quality Management, or related field.
• 4–6 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.