CAPA & Quality Systems Facilitator

AppLab Systems, Inc; Reedsville (PA); On-site; USD 85,000 - 125,000; Full time

Job summary

AppLab Systems, Inc. is seeking a quality systems professional to lead the end-to-end CAPA process in a fast-paced environment in Reedsville, PA.

You will investigate quality issues, coordinate cross-functional teams, and drive timely closure with effectiveness verification in line with FDA 21 CFR Part 820 and ISO 13485. The role emphasizes CAPA lifecycle management, deviation handling, and robust eQMS and metrics reporting to support audit readiness and continuous improvement across the

Qualifications

• Must have experience managing CAPA lifecycle from investigation to closure and verification.
• Strong ability to coordinate cross-functional teams and drive corrective actions.
• Proficiency with electronic Quality Management Systems (eQMS) and quality metrics reporting.

Responsibilities

• Facilitate and manage end-to-end CAPA process, from investigation to closure.
• Coordinate cross-functional teams to investigate quality issues and implement effective CAPAs.
• Monitor CAPA metrics and support audit readiness activities in line with FDA/ISO requirements.

Skills

CAPA Lifecycle Management

Nonconformance and Deviation

eQMS and Quality Metrics Reporting

Job description

AppLab Systems, Inc. is seeking a quality systems professional to lead the end-to-end CAPA process in a fast-paced environment in Reedsville, PA.

You will investigate quality issues, coordinate cross-functional teams, and drive timely closure with effectiveness verification in line with FDA 21 CFR Part 820 and ISO 13485. The role emphasizes CAPA lifecycle management, deviation handling, and robust eQMS and metrics reporting to support audit readiness and continuous improvement across the