Quality Systems & Regulatory Compliance Manager

Quality Systems & Regulatory Compliance Manager Location: near Waterbury, CT Salary: $90,000–$120,000 + Annual Bonus Potential + Benefits Benefits: Medical, Dental, Vision, 401(k) w/ match, Holidays, PTO Job Type: Full-Time | On-site Typical Hours: Monday–Friday, 40 hours/week Start Date: ASAP Sponsorship is not available Relocation assistance available Quality Systems & Regulatory Compliance Manager Description Our client in precision manufacturing is looking for a Quality Systems & Regulatory Compliance Manager to join its team near Waterbury, CT. You will own regulatory compliance and audit coordination, while partnering with a Quality Engineer to resolve customer complaints, conduct root-cause analysis and drive corrective and preventative actions. This role requires experience owning ISO 13485 compliance in a precision-manufacturing environment and audit participation. You must also understand FDA requirements, CAPA, and customer quality processes. This is a great opportunity to learn from the current leader during a planned transition before taking full ownership of the function at a financially strong manufacturer, investing in new technology, employee development, and long-term growth. Quality Systems & Regulatory Compliance Manager Responsibilities • Own regulatory and quality-system compliance programs • Maintain regulatory filings, certifications, and supporting records • Monitor FDA, ISO 13485, QMSR, ITAR, and EAR requirements • Coordinate customer complaints, root-cause analysis, and CAPAs • Lead customer audits and verify timely closure of findings • Manage internal audits, auditor training, and corrective actions • Track complaint trends, audit findings, PPM, and customer quality metrics • Escalate compliance risks and stop processes that violate requirements • Support customer quality agreements and document-control processes • Train teams on regulatory, audit, and documentation requirements Quality Systems & Regulatory Compliance Manager Qualifications • 7+ years of regulatory compliance or quality-system ownership experience required • ISO 13485 and FDA QMSR/21 CFR Part 820 compliance experience required • Customer complaints, CAPA, root-cause analysis, and audit experience required • Working knowledge of ITAR/EAR and environmental compliance required • Microsoft Office proficiency required