Medical Device Quality Engineer (Junior) - DFMEA & Validation

Capgemini; Pittsburgh (Allegheny County); On-site; USD 4,140,000 - 6,468,000; Full time

Job summary

Tundra Technical Solutions is seeking a Quality Engineer in the Pittsburgh area to support design quality during new product development. You will lead DFMEA, PFMEA, and risk assessments, ensure V&V alignment with requirements, and drive CAPA and nonconformance resolution.

A strong background in medical device quality, ISO 13485 and FDA QSR is required. Qualifications include a Bachelor's degree in Engineering or Quality and 3+ years in medical device quality engineering, with Minitab

Qualifications

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

Responsibilities

• Supports design quality activities throughout new product development, including design reviews and risk management.
• Lead and participate in DFMEA and risk assessments; participate in PFMEA and control plans.
• Review protocols and participate in V&V planning to ensure alignment with requirements.
• Support testing strategy and equipment qualification and process validation activities (IQ/OQ/PQ).
• Ensure compliance with FDA and international regulations in Design Control.
• Develops supplier qualification processes and PPAPs.
• Develops inspection techniques and implements inspection procedures.
• Manage and drive timely resolution of nonconformances and CAPAs.

Skills

DFMEA

PFMEA

V&V planning

Design Control

CAPA

MSA / Gage R&R

Statistical analysis

CQE / Six Sigma

Risk management

Quality engineering

Education

Bachelor’s degree in Engineering, Quality, or related field

Master’s degree preferred

Tools

Minitab

Job description

Tundra Technical Solutions is seeking a Quality Engineer in the Pittsburgh area to support design quality during new product development. You will lead DFMEA, PFMEA, and risk assessments, ensure V&V alignment with requirements, and drive CAPA and nonconformance resolution.

A strong background in medical device quality, ISO 13485 and FDA QSR is required. Qualifications include a Bachelor's degree in Engineering or Quality and 3+ years in medical device quality engineering, with Minitab