Quality Compliance Manager - Manufacturing (ISO 13485 exp. req. / Waterbury)

Location: near Waterbury, CT

Start Date: ASAP

About the role

Our client in precision manufacturing is looking for a Quality Compliance Manager to join their team. 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.

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

Requirements

• 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

Pay

$90,000–$120,000 + Annual Bonus Potential

Benefits

• Medical
• Dental
• Vision
• 401(k) with match
• Paid holidays
• Paid time off (PTO)

Schedule

• Full-Time | On-site
• Monday–Friday, 40 hours/week

Sponsorship is not available. Relocation assistance available.