Junior Medical Quality Engineer — Onsite Pittsburgh

Capgemini Engineering; Pittsburgh (Allegheny County); On-site; USD 65,000 - 90,000; Full time

Job summary

Capgemini Engineering in Pittsburgh, onsite, is seeking a Medical Junior Quality Engineer to support design quality activities across new product development and transfer. You will help ensure product quality from design through release with cross-functional collaboration.

The ideal candidate has 3+ years in medical device quality, strong knowledge of ISO 13485, FDA QSR, EU MDR, and hands-on experience with Design Control, V&V, and CAPA.

Qualifications

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

Responsibilities

• Supports design quality activities across new product development, including design reviews, requirements review, risk management, verification and validation planning, and design transfer readiness.
• Lead and participate in DFMEA and risk assessments. Participate in DFMEA, PFMEA, process flow, control plan, and risk assessment activities.
• Review protocols and participate in V&V planning to ensure alignment with product requirements and risk controls.
• Support testing strategy and documentation of equipment qualification and process validation activities (IQ/OQ/PQ, validation reports, production readiness).
• Support Design Control activities ensuring compliance with FDA and international regulations.
• Support supplier/process readiness activities, including supplier documentation review, inspection results, capability studies, MSA/Gage R&R, and PPAPs.
• Develop and execute supplier qualification processes, including supplier contracts and PPAPs.
• Develops various inspection techniques and procedures for product integrity and inspection documentation.
• Work with Metrology Lab on development of product gaging and collaborate with suppliers and manufacturing to resolve quality problems.
• Interface with Manufacturing Engineers to review processes for new products and coordinate validations and capability studies.

Skills

ISO 13485

FDA QSR 21 CFR 820

EU MDR

Risk management ISO 14971

Design Control

Process Validation

CAPA/NC

Supplier Quality

Statistical analysis

8D/DMAIC

CQE / Six Sigma

Education

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

Master’s degree preferred

Tools

Minitab

Gage R&R

Job description

Capgemini Engineering in Pittsburgh, onsite, is seeking a Medical Junior Quality Engineer to support design quality activities across new product development and transfer. You will help ensure product quality from design through release with cross-functional collaboration.

The ideal candidate has 3+ years in medical device quality, strong knowledge of ISO 13485, FDA QSR, EU MDR, and hands-on experience with Design Control, V&V, and CAPA.