Medical Device Quality Engineer

AppLab Systems, Inc; Reedsville (PA); On-site; USD 90,000 - 130,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

CAPA management

Root Cause Analysis

Quality metrics & trend analysis

Regulatory knowledge (FDA/ISO)

Design controls & validation support

Education

Bachelor's degree in Engineering

Job description

Support quality remediation and compliance initiatives by managing nonconformance, CAPA, deviation, complaint handling, and quality system activities. Perform quality assessments, root cause investigations, data analysis, and quality improvement initiatives while ensuring compliance with medical device regulations and standards.

Key Responsibilities:

• Manage CAPA, Nonconformance, and Deviation activities.
• Conduct Root Cause Analysis and corrective actions.
• Review quality metrics and identify recurring issues.
• Support quality audits and FDA readiness programs.
• Collaborate with cross-functional teams on quality improvements.

Required Skills:

• CAPA, Nonconformance, and Deviation Management.
• Root Cause Analysis (5 Why, Fishbone, FTA).
• Quality Metrics and Trend Analysis.
• FDA 21 CFR Part 820, ISO 13485, ISO 14971.
• Design Controls and Validation Support.

Preferred Qualifications:

• Bachelor's degree in Engineering discipline.
• 8+ years of Medical Device Quality experience.
• Experience with Class II/III medical devices.
• Experience supporting FDA, MDSAP, and ISO audits