Junior Medical Quality Engineer - DFMEA, Validation & CAPA

Capgemini; Oklahoma; On-site; USD 54,000 - 122,000; Full time

Benefits offered by this job

Paid time off

Medical, dental, and vision coverage

401(k) and retirement plans

Life and disability insurance

Job summary

Capgemini Engineering in the United States (Pittsburgh, PA) seeks a Medical Junior Quality Engineer to support design quality activities across new product development, DFMEA, and verification/validation efforts. The role involves collaboration with manufacturing, suppliers, and regulatory teams to ensure product integrity and regulatory compliance.

The ideal candidate holds a engineering degree, 3+ years in med device quality engineering, and knowledge of ISO 13485, FDA QSR, EU MDR, and risk

Qualifications

• Bachelor’s degree in Engineering, Quality, or related field.
• 3+ years of experience in medical device quality engineering.
• Knowledge of ISO 13485, FDA QSR (21 CFR Part 820), EU MDR, ISO 14971.

Responsibilities

• Support design quality activities across new product development.
• Lead DFMEA and risk assessments, participate in PFMEA and control plans.
• Ensure design transfer, validation, and supplier quality activities.
• Review protocols and support testing strategy and equipment qualification.
• Support CAPA, NC resolution and regulatory submissions.
• Coordinate with manufacturing, suppliers, and regulatory teams.

Skills

Design Control

Process Validation

CAPA

NC

Supplier Quality

Statistical Analysis

Minitab

8D

DMAIC

CQE

Education

Bachelor’s degree in Engineering

Master’s preferred

Tools

Minitab

Job description

Capgemini Engineering in the United States (Pittsburgh, PA) seeks a Medical Junior Quality Engineer to support design quality activities across new product development, DFMEA, and verification/validation efforts. The role involves collaboration with manufacturing, suppliers, and regulatory teams to ensure product integrity and regulatory compliance.

The ideal candidate holds a engineering degree, 3+ years in med device quality engineering, and knowledge of ISO 13485, FDA QSR, EU MDR, and risk