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QMS Consultant

Karwell Technologies

Blue Ash, OH

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JOB DETAILS
SKILLS
Biology, Biomedicine, Consulting, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Customer Relations, Delivery Management, External Audit, Failure Mode and Effects Analysis (FMEA), ISO (International Organization for Standardization), Industry Standards, Internal Audit, Maintain Compliance, Medical Equipment, Multitasking, Operations Processes, Quality Management, Regulations, Regulatory Compliance, Regulatory Requirements, Risk Analysis, Risk Management, Surveillance, Systems Maintenance, Time Management
LOCATION
Blue Ash, OH
POSTED
30+ days ago
Job Description:
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.

Requirements:

  • 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.

About the Company

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Karwell Technologies