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 manuf…
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$120k/yr
Full-time
bachelor degree
Posted 35d ago
~40 hrs/week
Responsibilities
Lead the site Quality organization to ensure the Quality Management System meets regulatory and customer requirements in an FDA-regulated environment. Oversee both QA and QC operations, including audits, CAPA systems, and final product release processes.
Requirements
Requires a Bachelor's degree in Engineering, Quality Management, or a related field with at least 10 years of experience in medical device quality. Must have proven expertise in ISO 13485, 21 CFR 820, and FDA regulatory requirements.
Full job description
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.
What You'll Do
Quality Assurance
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
Quality Control
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
What You Bring
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
Education
Bachelor's degree in Engineering, Quality Management, or a related field (or equivalent experience)
Location & Schedule
This is a fully on-site leadership role with initial location in Naples and relocation to Bonita Springs, FL site. First shift: Monday–Friday, 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.
Exalta is a global solutions provider for the MedTech industry, built to accelerate complex medical device programs from development through scalable manufacturing. By connecting development, regulatory, quality, and precision manufacturing within one integrated platform, EXALTA reduces handoffs, strengthens accountability, and gives leading OEMs a faster, more reliable path to bring breakthrough technologies to patients worldwide.
Offices: 89 S Commerce Way, 990, Bethlehem, Pennsylvania 18017, US · 83 S Commerce Way, 310, Bethlehem, Pennsylvania 18017, US · 12702 Trade Way Dr, Bonita Springs, Florida 34135, US
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