Quality Compliance Manager (ISO 13485 exp. req.)

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

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