Senior Medical Device Quality Leader - QMS & CAPA

Wipro; Reedsville (OH); Sur place; USD 125 000 - 277 000; Plein temps

Avantages offerts par ce poste

Medical and dental benefits

Disability insurance

Paid time off

Résumé du poste

Wipro Limited in the United States is seeking a Quality Manager to lead end-to-end quality remediation and compliance programs for medical devices, ensuring FDA, ISO 13485, and global regulatory alignment. This role focuses on QMS leadership, CAPA governance, audit readiness, and driving cross-functional improvements.

You will oversee CAPA, Nonconformance, Complaint, and Audit programs, support FDA inspections, monitor quality metrics, and guide cross-functional teams toward continuous

Qualifications

• Experience with Medical Device QMS required.
• Experience with FDA inspections and remediation programs.
• ISO 13485 Lead Auditor or ASQ/CQI certification preferred.
• 12+ years of Medical Device Quality experience.
• 5+ years of Quality Management leadership experience.

Responsabilités

• Lead QMS, CAPA, Nonconformance, Complaint, and Audit programs.
• Support FDA inspections and regulatory audits.
• Drive quality remediation and compliance initiatives.
• Monitor quality metrics and management reviews.
• Lead cross-functional quality improvement activities.

Connaissances

Medical Device QMS

CAPA

FDA 21 CFR Part 820/QMSR and ISO 13485

Risk Management

Quality Metrics

Formation

Bachelor's or Master's degree in Engineering or related discipline

Description du poste

Wipro Limited in the United States is seeking a Quality Manager to lead end-to-end quality remediation and compliance programs for medical devices, ensuring FDA, ISO 13485, and global regulatory alignment. This role focuses on QMS leadership, CAPA governance, audit readiness, and driving cross-functional improvements.

You will oversee CAPA, Nonconformance, Complaint, and Audit programs, support FDA inspections, monitor quality metrics, and guide cross-functional teams toward continuous