Quality engineer

Katalyst CRO; Reedsville (PA); On-site; USD 120,000 - 160,000; Full time

Job summary

Katalyst CRO is seeking a quality professional to support remediation and compliance for medical devices. You will manage CAPA, deviation and nonconformance activities, perform root cause investigations, data analysis, and drive quality improvements in line with FDA and ISO standards.

Responsibilities include supporting audits, review of quality metrics, and collaboration with cross-functional teams to ensure regulatory readiness and continuous improvement across the quality system.

Qualifications

• CAPA, nonconformance and deviation management experience.
• Root cause analysis and corrective actions.
• Review quality metrics and drive improvements.
• Support FDA readiness and quality audits.
• Collaborate with cross-functional teams on quality improvements.

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.

Skills

CAPA management

Nonconformance

Deviation management

Root Cause Analysis

Quality metrics

Trend analysis

FDA 21 CFR 820

ISO 13485

ISO 14971

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

Job Summary

• 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