Senior Medical Device Test Engineer - CAPA & QA Lead

Wipro; Reedsville (OH); In loco; USD 66.000 - 110.000; Tempo pieno

Descrizione del lavoro

Wipro Limited in Reedsville, PA (Day 1 onsite) seeks a Quality Engineer to develop multi‑module test cases, set up test environments, and prepare test evidence while validating system functionality for medical device projects. You will manage CAPA, nonconformance, and deviation activities; perform root cause analysis, data analysis, and support FDA readiness and audits.

Requirements include 8+ years of medical device quality experience and a Bachelor's degree in engineering; experience with

Competenze

• CAPA, Nonconformance, and Deviation management experience.
• Root Cause Analysis methods (5 Whys, Fishbone, FTA).
• Quality Metrics and Trend Analysis proficiency.
• Familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971.
• Design Controls and Validation support experience.

Mansioni

• 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.

Conoscenze

CAPA management

Nonconformance management

Deviation management

Root cause analysis

Quality metrics & trend analysis

Regulatory knowledge

Formazione

Bachelor's degree in Engineering

Descrizione del lavoro

Wipro Limited in Reedsville, PA (Day 1 onsite) seeks a Quality Engineer to develop multi‑module test cases, set up test environments, and prepare test evidence while validating system functionality for medical device projects. You will manage CAPA, nonconformance, and deviation activities; perform root cause analysis, data analysis, and support FDA readiness and audits.

Requirements include 8+ years of medical device quality experience and a Bachelor's degree in engineering; experience with