CAPA & Quality Systems Lead

Katalyst-Healthcares-; Reedsville (PA); On-site; USD 110,000 - 140,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a CAPA Manager to lead end-to-end CAPA processes in the medical device space, ensuring timely investigations, effective corrective actions, verification of effectiveness, and closure in accordance with FDA 21 CFR Part 820 and ISO 13485.

You will coordinate cross-functional teams, monitor CAPA metrics, and support audit readiness activities to maintain a robust quality management system throughout the product lifecycle.

Qualifications

• Bachelor's degree in Engineering or Life Sciences required.
• 8+ years of Medical Device Quality Systems experience.
• Minimum 3 years of CAPA management experience.
• Experience supporting regulatory audits and inspections.

Responsibilities

• Manage CAPA lifecycle from initiation to closure.
• Monitor CAPA timelines, aging, and effectiveness.
• Facilitate CAPA review meetings and follow-ups.
• Review CAPA documentation for compliance.
• Support audit and inspection readiness activities.

Skills

CAPA Lifecycle Management

Nonconformance & Deviation Management

Root Cause Analysis Techniques

eQMS & Quality Metrics Reporting

Regulatory Knowledge (FDA 21 CFR Part

Education

Bachelor's degree in Engineering or Life Sciences

Tools

eQMS

Job description

Job Summary:
Facilitate and manage the end-to-end CAPA process to ensure timely investigation, implementation, effectiveness verification, and closure of quality issues. Coordinate cross-functional teams, monitor CAPA metrics, support audit readiness activities, and maintain compliance with FDA and ISO quality system requirements.

Key Responsibilities:

• Manage CAPA lifecycle from initiation to closure.
• Monitor CAPA timelines, aging, and effectiveness.
• Facilitate CAPA review meetings and follow-ups.
• Review CAPA documentation for compliance.
• Support audit and inspection readiness activities.

Preferred Qualifications:

• Bachelor's degree in Engineering or Life Sciences.
• 8+ years of Medical Device Quality Systems experience.
• Minimum 3 years of CAPA management experience.
• Experience supporting regulatory audits and inspections.

Required Skills:

• CAPA Lifecycle Management.
• Nonconformance and Deviation Management.
• Root Cause Analysis Techniques.
• eQMS and Quality Metrics Reporting.
• FDA 21 CFR Part 820, ISO 13485, ISO 14971.