Junior Medical Quality Engineer: Design Control & Validation

Capgemini; Pittsburgh (Allegheny County); Hybrid; USD 54,000 - 122,000; Full time

Benefits offered by this job

Paid time off

Medical, dental, and vision coverage

Retirement savings plans (401k)

Life and disability insurance

Employee assistance programs

Job summary

Capgemini Engineering in Pittsburgh is seeking a Medical Junior Quality Engineer to strengthen design quality, risk management, and validation activities across medical device development. You will lead DFMEA/PFMEA, participate in design transfer, protocol review, and supplier quality initiatives, ensuring compliance with FDA QSR, ISO 13485, EU MDR, and related standards.

Collaboration with regulatory affairs and manufacturing is essential.

Qualifications

• Bachelor’s degree in Engineering, Quality, or related field; Master’s preferred.
• 3+ years in medical device quality engineering or related field.
• Strong knowledge of ISO 13485, FDA QSR (21CFR Part 820), EU MDR, ISO 14971.
• Experience with Design Control, Process Validation, CAPA, NC and Supplier Quality.
• Proficiency in statistical analysis tools and problem solving (8D, DMAIC).
• CQE or Six Sigma certification is a plus.

Responsibilities

• Supports design quality activities throughout new product development, including design reviews, requirements review, risk management, verification and validation planning, and design transfer readiness.
• Supports design transfer activities by ensuring product and process requirements are translated into manufacturing, inspection, supplier, validation, and release deliverables.
• Lead and participate in DFMEA and risk assessments.
• Review protocols and participate in V&V planning to ensure alignment with product requirements.
• Participate in protocol review and support testing strategy, ensuring robust verification and validation processes.
• Support execution and documentation of equipment qualification and process validation activities (IQ/OQ/PQ).
• Support Design Control and regulatory submissions (FDA/ international).
• Manage nonconformances (NCs) and CAPAs with cross-functional teams.

Skills

Quality engineering

FDA QSR

ISO 13485

Risk management

Statistical analysis

Minitab

Education

Bachelor’s degree in Engineering

Master’s degree preferred

Tools

Minitab

CAPA tools

Job description

Capgemini Engineering in Pittsburgh is seeking a Medical Junior Quality Engineer to strengthen design quality, risk management, and validation activities across medical device development. You will lead DFMEA/PFMEA, participate in design transfer, protocol review, and supplier quality initiatives, ensuring compliance with FDA QSR, ISO 13485, EU MDR, and related standards.

Collaboration with regulatory affairs and manufacturing is essential.