Quality Specialist

US-IN-Indianapolis
Job ID
2017-7872
Category
Quality/Regulatory Compliance
Company Name
TriMedx, LLC

Overview

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.

Responsibilities

  • 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

Qualifications

  • 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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