Senior Medical Device QA Engineer: CAPA & FDA Readiness

Wipro; Reedsville (OH); On-site; USD 45,000 - 110,000; Full time

Benefits offered by this job

Medical and dental benefits

Disability insurance

Paid time off

Sick leave

Leave options

Job summary

Wipro Limited, a leading technology services and consulting firm, is seeking a Quality Engineer to develop multi‑module test cases, set up test environments, and prepare test evidence. The role is onsite at Reedsville, PA, focusing on quality remediation, CAPA, deviation handling, and regulatory compliance in medical device contexts.

The candidate will perform root cause analyses, data-driven quality improvements, and support FDA readiness programs while collaborating with cross-functional teams

Qualifications

• CAPA, nonconformance and deviation management experience.
• Root cause analysis techniques.
• Quality metrics and trend analysis experience.
• Familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971.
• Design controls and validation support.

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.

Skills

CAPA, Nonconformance, Deviation Mgmt

Root Cause Analysis

Quality Metrics & Trend Analysis

FDA 21 CFR Part 820, ISO 13485, ISO 18

Design Controls

Education

Bachelor's degree in Engineering

Job description

Wipro Limited, a leading technology services and consulting firm, is seeking a Quality Engineer to develop multi‑module test cases, set up test environments, and prepare test evidence. The role is onsite at Reedsville, PA, focusing on quality remediation, CAPA, deviation handling, and regulatory compliance in medical device contexts.

The candidate will perform root cause analyses, data-driven quality improvements, and support FDA readiness programs while collaborating with cross-functional teams