Lead Medical Device Quality Architect

Wipro; Reedsville (OH); On-site; USD 80,000 - 158,000; Full time

Benefits offered by this job

Medical and dental benefits

Disability insurance

Paid time off

Job summary

Wipro Limited is seeking a Quality Lead in Reedsville, PA (Day 1 onsite) to drive manufacturing quality assessment, remediation, and continuous improvement for Class II/III medical devices. You will evaluate processes, validations, risk management, supplier quality, and regulatory compliance (FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, MDSAP) to improve yield and reduce defects.

The role entails leading CAPA, nonconformance, and supplier quality issues, supporting audits, and delivering

Qualifications

• Lead manufacturing quality assessments and process audits.
• Drive FPY improvement and defect reduction initiatives.
• Review process validation (IQ/OQ/PQ) and risk management activities.
• Manage CAPA, nonconformance, and supplier quality issues.
• Support FDA, ISO 13485, MDSAP, and regulatory audits

Responsibilities

• Lead manufacturing quality assessments and process audits.
• Drive FPY improvement and defect reduction initiatives.
• Review process validation (IQ/OQ/PQ) and risk management activities.
• Manage CAPA, nonconformance, and supplier quality issues.
• Support FDA, ISO 13485, MDSAP, and regulatory audits

Skills

Manufacturing Quality Engineering

Process Validation

SPC

MSA

PFMEA

CAPA Management

FDA 21 CFR Part 820

ISO 13485

ISO 14971

Education

Bachelor's/Master's degree in Engineering

Job description

Wipro Limited is seeking a Quality Lead in Reedsville, PA (Day 1 onsite) to drive manufacturing quality assessment, remediation, and continuous improvement for Class II/III medical devices. You will evaluate processes, validations, risk management, supplier quality, and regulatory compliance (FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, MDSAP) to improve yield and reduce defects.

The role entails leading CAPA, nonconformance, and supplier quality issues, supporting audits, and delivering