Job Summary: Lead quality remediation and compliance programs for medical devices, ensuring adherence to FDA, ISO 13485, and global regulatory requirements. Provide leadership for QMS processes, audit readiness, CAPA governance, quality metrics, and continuous improvement initiatives across cross-functional teams.
Key Responsibilities:
Lead QMS, CAPA, Nonconformance, Complaint, and Audit programs.
Support FDA inspections and regulatory audits.
Drive quality remediation and compliance initiatives.
Monitor quality metrics and management reviews.
Lead cross-functional quality improvement activities
Medical Device Quality Management Systems (QMS).
CAPA, Nonconformance, Complaint, and Audit Management.
FDA 21 CFR Part 820/QMSR and ISO 13485.
Risk Management and Design Controls.
Quality Metrics, Remediation, and Compliance Programs.
Education & Experience:
Bachelor's or master's degree in engineering or related discipline.
12+ years of Medical Device Quality experience.
5+ years of Quality Management leadership experience.
ISO 13485 Lead Auditor or ASQ/CQI certification preferred.
Experience supporting FDA inspections and remediation programs
Numbers & Facts
Location
plymouth, NH
Skills
American Society for Quality (ASQ)unmatched
Auditingunmatched
Code of Federal Regulationsunmatched
Continuous Improvementunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
FDA (Food and Drug Administration)unmatched
FDA Requirementsunmatched
Healthcare Qualityunmatched
Healthcare Softwareunmatched
ISO (International Organization for Standardization)unmatched
Leadershipunmatched
Maintain Complianceunmatched
Medical Equipmentunmatched
Quality Managementunmatched
Quality Metricsunmatched
Quality Monitoringunmatched
Regulatory Requirementsunmatched
Risk Managementunmatched
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