About this role
Quality Compliance Manager (ISO 13485 exp. req.) 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 Compliance Manager Description Our client in precision manufacturing is looking for a Quality Compliance Manager to join their team near Waterbury, CT. You will own regulatory compliance, quality-system administration, and audit readiness while partnering with the Quality Engineer on customer complaints, root-cause analysis, and corrective and preventative actions. This role requires experience managing ISO 13485 compliance within a regulated manufacturing environment, along with strong knowledge of FDA QMSR/21 CFR Part 820 requirements, CAPA, audits, and customer quality processes. You will also support ITAR/EAR and other applicable compliance requirements. 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 Compliance Manager Responsibilities • Own regulatory compliance and quality-system programs • Maintain regulatory registrations, certifications, and compliance records • Maintain ISO 13485 compliance and support FDA QMSR/21 CFR Part 820 requirements • Monitor applicable FDA, ITAR, EAR, and environmental requirements • Lead customer, regulatory, and internal audit coordination • Manage internal audit schedules, auditor training, and corrective actions • Lead customer audits and verify timely closure of findings • Partner with Quality Engineering on customer complaints, root-cause analysis, and CAPAs • Ensure timely closure of audit findings and corrective actions • Track complaint trends, audit findings, PPM, and customer quality metrics • Support customer quality agreements and document-control processes • Train employees on regulatory, audit, and documentation requirements • Escalate compliance risks and stop processes that violate requirements Quality Compliance Manager Qualifications • 5+ years of manufacturing compliance and quality systems experience required • Experience owning or maintaining an ISO 13485 quality management system required • 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