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Sarasota, FL 34234 US
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.
- 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.
The job-related activities would take place primarily in an office environment.
- 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.