Quality Compliance Manager (ISO 13485 exp. req.)

Quality Compliance Manager (ISO 13485 exp. req.)
Location: near Waterbury CT
Salary: $90000$120000 Annual Bonus Potential Benefits
Benefits: Medical Dental Vision 401(k) w/ match Holidays PTO
Job Type: Full-Time On-site
Typical Hours: MondayFriday 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