This job is posted on behalf of Prestige Recruiting Firm by Top Echelon.
This is an opportunity to join an established medical device manufacturer in the Clearwater area that continues to invest in product development and expanding its presence in the market. The company has seen recent growth, continues to advance its technology, and is focused on bringing new solutions to the medical community.
The Sustaining Quality Engineer will have ownership of validation programs while working closely with manufacturing and engineering to improve product quality, reliability, and processes. This isn't strictly a documentation or compliance role. You'll be involved in day-to-day manufacturing challenges, process improvements, and quality decisions that directly impact products used by physicians and their patients.
The Sustaining Quality Engineer maintains the quality, compliance, and performance of post-market medical device products and their associated manufacturing processes. This role ensures adherence to regulatory standards while supporting validation, change management, and continuous improvement initiatives across production.
Responsibilities• Support change management activities to ensure compliant and timely implementation of product and process updates
• Maintain and update technical documentation, including specifications,validations, and quality records
• Ensure manufacturing processes consistently meet product specifications and regulatory requirements
• Own and manage validation programs, including IQ/OQ/PQ and revalidation
• Monitor production quality and drive improvements in process performance and activities consistency
• Analyze data to evaluate trends, process capability, and risk
• Develop and maintain statistical process controls and sampling plans
• Create and execute test methods to support product enhancements and component changes
• Lead or support non-conformance investigations, root cause analysis, and CAPA
• Partner cross-functionally to drive continuous improvement across manufacturing activities and quality systems
• Ensure compliance with applicable medical device regulations and standards
Qualifications• Bachelor’s degree in Engineering or related technical field
• 3–5+ years of experience in medical device quality, manufacturing, or
engineering
• Experience supporting validation activities (IQ/OQ/PQ) and test method
development
• Strong understanding of quality systems and change control in regulated
environments
• Familiarity with FDA 21 CFR Part 820, ISO 13485, and global regulatory frameworks
• Proficiency in statistical analysis and quality tools (e.g., Minitab or equivalent)
• Experience with root cause analysis, CAPA, and risk management methodologies
(e.g., FMEA)