Quality Assurance & Quality Control Manager

At EXALTA Group, quality is more than compliance — it's the foundation of everything we do. As a trusted partner to the world's leading medical device companies, we manufacture products that improve patient outcomes and help make MedTech better.

We're seeking a collaborative, hands-on Quality Assurance & Quality Control Manager to lead our site Quality organization on Florida's Gulf Coast. In this role, you'll drive a culture of operational excellence, continuous improvement, and regulatory compliance — partnering closely with Operations, Engineering, Supply Chain, and Regulatory Affairs to deliver exceptional quality, customer satisfaction, and business performance.

The ideal candidate is a visible leader who thrives in a fast-paced manufacturing environment, builds high-performing teams, and balances uncompromising quality standards with a practical, solutions-oriented approach. If you're passionate about developing people, strengthening quality systems, and driving continuous improvement in an FDA-regulated, ISO 13485-certified medical device environment, we invite you to join us as we continue to grow and transform our business.

• Serve as the designated Management Representative, ensuring the Quality Management System (QMS) meets regulatory and customer requirements
• Lead Management Reviews and communicate QMS performance to top management
• Plan and lead internal audits, and serve as the primary liaison for external audits — including regulatory inspections, certification body audits, and customer audits
• Maintain compliance with ISO 13485, 21 CFR 820, and other applicable standards, keeping the QMS current as regulations evolve
• Manage the complaint handling process, ensuring timely investigation, root cause analysis, and resolution
• Own the CAPA system, driving timely identification, investigation, and resolution of issues
• Oversee the nonconformance program, ensuring proper documentation, investigation, and disposition
• Direct supplier evaluation, approval, and monitoring processes to ensure supplier quality
• Ensure equipment calibration and preventive maintenance schedules are implemented and maintained in compliance with regulatory requirements
• Develop and update quality policies, procedures, and work instructions
• Monitor and report key quality metrics to management, driving accountability and improvement

• Manage quality lab operations to ensure timely, efficient inspection and release of product
• Prioritize inspection workflow to meet production and customer requirements
• Ensure quality inspectors perform inspections according to established procedures and protocols
• Regularly review inspection records and results for accuracy and compliance
• Oversee the final product release process, ensuring all inspections and documentation are complete and compliant

• 10+ years of quality assurance/quality control experience in the medical device industry
• Proven, hands-on expertise with ISO 13485:2016, 21 CFR 820, and FDA regulatory requirements
• A track record of leading audits, CAPA management, and supplier quality management
• Strong leadership and team-development skills with a visible, hands-on style
• Ability to read blueprints and interpret GD&T requirements from customer specifications
• Superior decision-making, problem-solving, and conflict management abilities
• Excellent communication and interpersonal skills for collaboration with internal and external stakeholders

Bachelor's degree in Engineering, Quality Management, or a related field (or equivalent experience)

This is a fully on-site leadership role with initial location in Naples and relocation to Bonita Springs, FL site. First shift: Monday–Thursday, 6:00 AM–4:30 PM.

EXALTA is an Equal Opportunity Employer. We respect every employee as an individual, and we hire and promote based on qualifications, performance, and potential — without regard to race, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.