Medical Device Quality Leader: QMS & Compliance

Katalyst-Healthcares-; Greensboro (NC); On-site; USD 140,000 - 190,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a senior quality leader to oversee remediation and compliance for medical devices, ensuring adherence to FDA, ISO 13485, and global regulatory requirements.

You will provide strategic direction for QMS, CAPA governance, audits, metrics, and continuous improvement across cross-functional teams.

This role also drives readiness for FDA inspections and supports remediation programs across the organization.

Qualifications

• Experience in Medical Device QMS implementation and maintenance.
• Expertise CAPA, nonconformance, complaints, and audits.
• Knowledge of FDA 21 CFR Part 820, QMSR, and ISO 13485.
• Strong risk management and design controls.
• Experience with quality metrics 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.

Skills

QMS for Medical Devices

CAPA Management

Nonconformance Handling

Audit Management

FDA/ISO Regulatory Knowledge

Risk Management

Design Controls

Education

Bachelor's or Master's degree in Engineering or related discipline

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.

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