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.
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.
Required Skills: - 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.
Preferred Qualifications: - 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
