Medical Device Quality Manager
Posted Sep 29, 2026 · 5h ago
- Location
- Reedsville, Pennsylvania, United States
- Seniority
- Lead
- Listing language
- English
Description
Job Summary: Lead quality remediation and compliance programs for medical devices, ensuring adherence to FDA, ISO 13485, and global regulatory
requirements
.
Provide leadership for QMS processes, audit readiness, CAPA governance, quality metrics, and continuous improvement initiatives across cross-functional teams.
Key
Responsibilities
Lead QMS, CAPA, Nonconformance, Complaint, and Audit programs.
Support FDA inspections and regulatory audits.
Drive quality remediation and compliance initiative…