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QMS Coordinator

Sarasota, FL 34234

Posted: 08/11/2023 Job Type: Permanent/Direct Hire Industry: Engineering Job Number: 23078 Pay Rate: $ 55000.00 - $ 65000.00

Job Description

Our client, a Medical Device Manufacturer in Sarasota is seeking a QMS Coordinator


This position reports directly to the Quality Assurance Director. This person will need to be confident in working on cross-functional teams and serve as a key resource in the management of Quality Management Systems including CAPA and Complaint, monitoring and management of quality projects, etc. 


Quality Engineer Deliverables:

  • Ensure complaint evaluations are conducted and analyze trends. 
  • Data analysis and trending of non-conforming material disposition.
  • Participate in GEMBA and cross-functional meetings.
  • Help lead Root Cause Analysis for CAPA responses.
  • Participate in Internal audits and supports improvement activities.
  • Help execute effective quality systems, procedures and/or processes within cross functional teams to ensure compliance and efficiency throughout our quality system.
  • Interact with internal partners for development of best practices in our quality systems and procedures.
  • Ensure Customer complaint investigations, CAPA investigations, procedures and other activities comply with FDA Quality System Regulations.
  • Experience with multiple quality systems such as Audits, Complaints, CAPA, Non-Conformance, Change Control, Design Controls, Document Control and trending 
  • Develop professional expertise, apply company policies and procedures to resolve a variety of quality systems issues, conduct gap analysis.
  • Prepare audit and product evaluation schedules.
  • Perform investigations, documents findings, and make recommendation for improvement activities.


Key Accountabilities:

  • Oversee all customer returns (OOBF, Warranty, Complaints, RMAs, etc.)
  • Failure analysis of returns, lessons learned, trends, feedback.
  • Quality Subject Matter Expert for the QMS areas
  • Supports Quality managers in their absence.


Work Environment:

            The job-related activities would take place primarily in an office environment.

Job Requirements


  • 4+ years of experience in quality systems, quality assurance, or a similar role.



  • Degree and experience in engineering or life sciences. 



  • Experience with a medical device manufacturer and compliance with ISO 13485 and the FDA is preferred.
  • Excellent communication skills, both verbal and written. 
  • Ability to effectively present information and lead teams. 
  • Strong analytical and problem-solving skills.
  • Self-motivated and proactive with strong customer service orientation.
  • Ability to establish and maintain effective and cooperative working relationships with those contacted in the course of work.
  • Experience with data organization and presentation.
  • Excellent project management skills.
  • Intermediate or above skill in the use of Microsoft Office Suite required.
  • Project completion driven.
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