CAPA & Quality Systems Lead

AppLab Systems, Inc; Reedsville (PA); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Job summary

AppLab Systems, Inc. is seeking an experienced CAPA and Quality Systems professional to lead end-to-end CAPA processes. The role requires coordinating cross-functional teams, monitoring timelines, and ensuring readiness for audits and inspections.

You will review CAPA documentation, oversee lifecycle management, and report on quality metrics while maintaining compliance with FDA and ISO requirements. A strong background in medical device quality systems is essential.

Qualifications

• Bachelor's degree in Engineering or Life Sciences is required.
• 8+ years of Medical Device Quality Systems experience.
• Minimum 3 years of CAPA management experience.
• Experience supporting regulatory audits and inspections.
• Familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971.
• Ability to coordinate cross-functional teams and manage CAPA lifecycle.

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.
• CAPA Lifecycle Management.
• Nonconformance and Deviation Management.
• eQMS and Quality Metrics Reporting.
• Understand FDA and ISO quality system requirements.

Skills

CAPA management

Quality systems

Regulatory compliance

Cross-functional coordination

Audits & inspections

Documentation review

Troubleshooting

Education

Bachelor's degree in Engineering or Life Sciences

Tools

eQMS

QMS software

Job description

AppLab Systems, Inc. is seeking an experienced CAPA and Quality Systems professional to lead end-to-end CAPA processes. The role requires coordinating cross-functional teams, monitoring timelines, and ensuring readiness for audits and inspections.

You will review CAPA documentation, oversee lifecycle management, and report on quality metrics while maintaining compliance with FDA and ISO requirements. A strong background in medical device quality systems is essential.