Quality Engineering Manager

Location:

Gainesville ,

Florida Type:

Direct Hire Job #11639

Salary:

$150000

Location Type:

On-Site The Quality Engineering Manager will provide leadership to the Quality Engineering team and partner cross-functionally with Engineering, Manufacturing, Operations, Regulatory Affairs, and Supply Chain to ensure products are designed, manufactured, and maintained in accordance with applicable regulatory requirements and quality standards. This role will oversee quality activities throughout the product lifecycle, including design controls, risk management, process validation, complaint handling, CAPA, audits, and continuous improvement initiatives. This individual will be responsible for ensuring compliance with FDA regulations, ISO 13485, MDSAP, EU MDR, and internal Quality Management System (QMS) requirements while fostering a culture of quality throughout the organization. Required Qualifications Bachelor's Degree in Science, Engineering, or a related technical discipline from an accredited institution and managerial experience Minimum of 7 years of Quality Engineering, Quality Assurance, or Quality Systems experience within the medical device industry or combined aerospace and medical device experience. Demonstrated knowledge of FDA Quality System Regulations, ISO 13485, MDSAP, and medical device quality system requirements. Experience supporting product development and manufacturing activities, including design controls, risk management, verification and validation, and process validation. Working knowledge of inspection specification development, statistical analysis techniques, gage R&R studies, and GD&T applications. Experience leading or participating in root cause investigations, CAPA activities, complaint investigations, and nonconformance management. Prior experience supporting FDA inspections, notified body audits, and external quality audits. Excellent verbal and written communication skills. Strong leadership, organizational, and problem-solving abilities. Ability to effectively collaborate and influence cross-functional teams across all levels of the organization. Preferred Qualifications Master's Degree in Science, Engineering, or a related technical discipline. Implantable medical device industry experience. Experience leading Quality Engineering teams supporting both new product development and commercial manufacturing. Demonstrated success driving continuous improvement initiatives and quality system enhancements. ASQ certifications such as Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent.