CAPA & Quality Systems Lead

Creative Solutions Services, LLC; 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

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.