QMS Coordinator

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.

Requirements:

Education:

Skills:

• 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.