Quality Lead With Medical Device

Talent Groups; Reedsville (PA); On-site; USD 90,000 - 130,000; Full time

Job summary

Talent Groups is seeking a Quality Assurance professional to support remediation and compliance initiatives for medical device quality systems. The role focuses on managing CAPA, nonconformance, deviations, and complaint handling, while performing data analysis and root cause investigations to drive improvements.

Ideal candidates have 8+ years in medical device quality, experience with FDA/MDSAP audits, and a strong understanding of ISO 13485 and ISO 14971.

Qualifications

• Knowledge of CAPA, nonconformance, and deviation management.
• Experience with root cause analysis methodologies (5 Why, Fishbone, FTA).
• Familiarity with medical device quality system standards (FDA 21 CFR Part 820, ISO 13485, ISO 14971).
• Experience with design controls and validation support.

Responsibilities

• Manage CAPA, nonconformance, and deviation activities.
• Conduct Root Cause Analysis and 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 & Nonconformance

Root Cause Analysis

Quality Metrics

Regulatory Standards

Design Controls

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