Quality Lead

About the role

Location: Reedsville, PA (Day 1 Onsite). 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.

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, 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.

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.