Quality Manager

JobDiva, Inc.; Plymouth (NH); On-site; USD 150,000 - 210,000; Full time

Job summary

JobDiva, Inc. in the United States is seeking a senior Quality leader to drive QMS remediation, CAPA governance, and regulatory compliance for medical devices across cross-functional teams.

You will lead FDA inspections readiness, maintain ISO 13485 alignment, and champion continuous improvement through metrics, design controls, and risk management. Strong leadership and global regulatory experience are essential.

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

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.

Skills

QMS leadership

Regulatory compliance

CAPA governance

FDA inspections

Education

Bachelor's or master's in engineering or related

Job description

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