Role: Quality Lead Location: Reedsville, PA (Day 1 Onsite)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 standardsKey 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.
