Medical Device Quality Architect L1 (Contract)

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

Benefits offered by this job

Medical & dental benefits

Disability insurance

Paid time off

Job summary

Wipro Limited seeks a Product Architect L1 (Contract) in Ohio to lead manufacturing quality assessments for Class II/III medical devices, ensuring FDA/ISO/MDSAP compliance and CAPA-driven improvements. This role partners with delivery teams to drive risk management and process validation across regulated manufacturing environments.

The position demands 8–10 years of experience in medical device quality, with on-site collaboration in Reedsville, PA, and readiness for audits and inspections.

Qualifications

• 8–10 years of Medical Device Manufacturing Quality experience.
• Experience with Class II/III medical devices.
• Knowledge of FDA 21 CFR Part 820 and ISO 13485.
• Experience supporting regulatory audits and inspections.
• Bachelor's or Master's degree in engineering.

Responsibilities

• Lead manufacturing quality assessments and process audits.
• Drive FPY improvement and defect reduction initiatives.
• Review 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 Eng

Process Validation

SPC/MSA/PFMEA

CAPA & Nonconformance

FDA 21 CFR Part 820 & ISO 14971

Education

Bachelor's/Master's in Engineering

8+ years Medical Device QA

Job description

Wipro Limited seeks a Product Architect L1 (Contract) in Ohio to lead manufacturing quality assessments for Class II/III medical devices, ensuring FDA/ISO/MDSAP compliance and CAPA-driven improvements. This role partners with delivery teams to drive risk management and process validation across regulated manufacturing environments.

The position demands 8–10 years of experience in medical device quality, with on-site collaboration in Reedsville, PA, and readiness for audits and inspections.