Junior Medical Quality Engineer: Shape Safer Devices

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

Benefits offered by this job

Paid time off

Medical, dental, and vision coverage

Retirement savings plans

Life and disability insurance

Employee assistance programs

Job summary

Capgemini Engineering is seeking a Medical Junior Quality Engineer for an onsite role in Pittsburgh, PA. You will support design quality activities, participate in DFMEA/PFMEA, and ensure design transfer readiness across NPD and manufacturing processes.

The role emphasizes Design Control compliance with FDA and international regulations, V&V planning, and supplier quality. Strong problem-solving and statistical skills are required.

Qualifications

• Bachelor’s degree in Engineering, Quality, or a related field (Master’s preferred).
• 3+ years of experience in medical device quality engineering or a related field.
• Strong knowledge of ISO 13485, FDA QSR (21 CFR Part 820), EU MDR, and risk management (ISO 14971).
• Experience with Design Control, Process Validation, CAPA, NC and Supplier Quality.

Responsibilities

• Supports design quality activities across new product development, including design reviews and risk management.
• Lead and participate in DFMEA, PFMEA, process flow, control plan and risk assessment activities.
• Review protocols and participate in V&V planning to align with product requirements.
• Support testing strategy and documentation of equipment qualification and process validation.

Skills

DFMEA

PFMEA

Design Control

CAPA

NC handling

Minitab

8D / DMAIC

Risk Management

IQ/OQ/PQ

Education

Bachelor’s degree in Engineering or Quality

Master’s degree preferred

Tools

Minitab

Job description

Capgemini Engineering is seeking a Medical Junior Quality Engineer for an onsite role in Pittsburgh, PA. You will support design quality activities, participate in DFMEA/PFMEA, and ensure design transfer readiness across NPD and manufacturing processes.

The role emphasizes Design Control compliance with FDA and international regulations, V&V planning, and supplier quality. Strong problem-solving and statistical skills are required.