Senior Medical Device Quality Engineer - CAPA & Compliance

AppLab Systems, Inc; Reedsville (PA); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

AppLab Systems, Inc. is seeking a seasoned quality professional to support remediation and compliance initiatives within medical device manufacturing.

You will manage CAPA, nonconformance, deviation, and complaints, perform root cause analysis, data review, and drive quality improvements to ensure FDA readiness and regulatory compliance. This role partners with cross-functional teams to uphold quality standards and drive continuous improvement.

Qualifications

• CAPA, nonconformance and deviation management.
• Root cause analysis using 5 Why, Fishbone, and FTA.
• Quality metrics review and trend analysis.
• Familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971.
• Design controls and validation support.

Responsabilités

• Manage CAPA, nonconformance, and deviation activities.
• Conduct root cause analysis and implement corrective actions.
• Review quality metrics and identify recurring issues.
• Support FDA readiness programs and quality audits.
• Collaborate with cross-functional teams on quality improvements.

Connaissances

CAPA management

Root Cause Analysis

Quality metrics & trend analysis

Regulatory knowledge (FDA/ISO)

Design controls & validation support

Formation

Bachelor's degree in Engineering

Description du poste

AppLab Systems, Inc. is seeking a seasoned quality professional to support remediation and compliance initiatives within medical device manufacturing.

You will manage CAPA, nonconformance, deviation, and complaints, perform root cause analysis, data review, and drive quality improvements to ensure FDA readiness and regulatory compliance. This role partners with cross-functional teams to uphold quality standards and drive continuous improvement.