Quality Specialist

Job ID
Quality/Regulatory Compliance
Company Name
TriMedx, LLC


The Quality Specialist is responsible for supporting equipment operations quality as it pertains to compliance with regulations, standards, policies and procedures.  The Quality Specialist I will be responsible for providing support  of a Total Quality Management System, to include assistance with audits, risk analysis and process improvement initiatives.  The Quality Specialist will participate in field/internal audits, creation of quality audit reports and communication of potential non-compliance issues to the Manager.  This positions is responsiblie for acting as a general resource to TriMedx Operations.


  • Promoting quality achievement and performance improvement throughout the organization
  • Support and assist with on-site quality audits to review policy compliance
  • Support and assist with nternal quality audits to ensure alignment of external and internal TriMedx processes
  • Create, monitor and manage Corrective and Preventive Action Plans
  • Develop, implement, communicate and maintain the QMS to bring the Company’s Quality Systems and Procedures into compliance with quality system requirements
  • Cross train and support compliance related actitivies within the department
  • Research and provide feedback regarding TRIMEDX policy and procedure revisions
  • Management and oversight of TriMedx potential Medical Device Incident Process
  • Collaboration and relationship building with hospital risk and quality as necessary
  • Support quality standards and metrics that drive operations performance
  • Apply and articulate Good/Best Practices
  • Provide education support and guidance for Root Cause Analysis and CAPA execution
  • Identify and support quality related training and education
  • Analysis of equipment management trends and collaboration with TriMedx Operations to identify trends
  • Acknowledge and assist with resolution of incoming Quality service tickets
  • Provide support for regulation and standards guidance to TriMedx Operations
  • Provide guidance to TriMedx Operations questions and concerns
  • Collaborate with TriMedx Operations to define execute continuous improvement opportunities
  • Provide guidance and support during potential Incident/complaint investigations


  • Bachelor’s Degree in an applied science or engineering field
  • Minimum of 1-3 years of experience in engineering, healthcare quality and/or risk, or medical device industry required
  • Experience with CAPA Management and Root Cause Analysis process
  • Experience with Complaint /Incident investigation
  • Knowledge of Quality Management System, process controls, and/or Continuous Improvement
  • Knowledge of FDA regulations, Clinical Engineering regulations and standards, and/or ISO standards preferred
  • Working knowledge of Quality Management System
  • Knowledge of Microsoft Office applications required
  • Ability to manage time and set priorities amidst multiple tasks and deadlines
  • Ability to work effectively with other team members, as well as independently
  • Excellent interpersonal, listening, and interviewing skills
  • Excellent presentation and facilitation skills
  • Strong written and verbal communication skills


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