Quality Manager

Katalyst CRO; Plymouth (NH); On-site; USD 130,000 - 170,000; Full time

Job summary

Katalyst CRO is seeking an experienced Quality Leader to drive remediation and compliance programs for medical devices, ensuring adherence to FDA, ISO 13485, and global regulatory requirements. You will provide leadership for QMS processes, audit readiness, CAPA governance, quality metrics, and continuous improvement across cross-functional teams.

Role requires extensive experience in medical device quality, regulatory inspections support, and leadership of cross-functional quality initiatives,

Qualifications

• Bachelor’s or Master’s degree in engineering or related discipline.
• 12+ years Medical Device Quality experience.
• 5+ years 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

Leadership

Regulatory knowledge

Quality metrics

Education

Bachelor's or master's degree in engineering or related discipline

12+ years Medical Device Quality experience

5+ years Quality Management leadership experience

ISO 13485 Lead Auditor or ASQ/CQI certification preferred

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.

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