Junior Medical Quality Engineer – Onsite Pittsburgh

Capgemini; Pittsburg (CA); On-site; USD 54,000 - 122,000; Full time

Benefits offered by this job

Paid time off

Medical coverage

Retirement plans

Job summary

Capgemini Engineering, a world leader in engineering services, is hiring a Medical Junior Quality Engineer for an onsite role in Pittsburgh, PA. You will support design quality activities across new product development, perform DFMEA, risk assessments, and ensure V&V alignment with design requirements.

The role requires a Bachelor’s in Engineering/Quality, 3+ years in medical device quality, and strong ISO/FDA knowledge. Proficiency with Minitab and 8D/DMAIC is desired, CQE or Six Sigma a plus.

Qualifications

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

Responsibilities

• Supports design quality activities throughout new product development, including design reviews and risk management.
• Lead DFMEA and risk assessments.
• Review protocols and V&V planning to ensure alignment with requirements.
• Support equipment qualification and process validation activities (IQ/OQ/PQ).
• Ensure compliance with FDA and international regulations.
• Collaborate with Manufacturing and suppliers on CAPAs and problem solving.

Skills

Quality engineering

Statistical analysis

Problem solving

Regulatory knowledge

Education

Bachelor’s degree in Engineering/Quality

Master’s preferred

Tools

Minitab

Job description

Capgemini Engineering, a world leader in engineering services, is hiring a Medical Junior Quality Engineer for an onsite role in Pittsburgh, PA. You will support design quality activities across new product development, perform DFMEA, risk assessments, and ensure V&V alignment with design requirements.

The role requires a Bachelor’s in Engineering/Quality, 3+ years in medical device quality, and strong ISO/FDA knowledge. Proficiency with Minitab and 8D/DMAIC is desired, CQE or Six Sigma a plus.