Junior Medical Device Quality Engineer: Design & Validation

TALENT Software Services; Pittsburgh (Allegheny County); On-site; USD 85,000 - 110,000; Full time

Job summary

TALENT Software Services in Pittsburgh seeks a Medical Device Quality Engineer to support design quality activities across new product development, DFMEA, PFMEA, and design transfer readiness.

You will ensure compliance with FDA QSR and ISO 13485, participate in verification and validation planning, supplier qualification, CAPA, and problem-solving using DMAIC; bachelor's in engineering; 3+ years required.

Qualifications

• Bachelor's degree in Engineering, Quality, or a related field; a Master’s degree is 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 ISO 14971.
• Experience with Design Control, Process Validation, CAPA, 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 and design transfer readiness.
• Lead and participate in DFMEA/PFMEA, process flow, and risk assessment activities.
• Review protocols and support verification/validation planning and testing strategies.
• Support supplier qualification, contracts, and PPAPs; ensure supplier documentation and results meet requirements.
• Assist with complaint investigations and CAPA; interface with Regulatory Affairs for submissions.
• Manage timely resolution of nonconformances and drive corrective actions.

Skills

ISO 13485 knowledge

FDA QSR knowledge

EU MDR knowledge

Risk management (ISO 14971)

Design Control

Process Validation

CAPA

Supplier Quality

CQE or Six Sigma

8D, DMAIC problem solving

Statistical analysis (Minitab)

Education

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

Master's degree preferred

Tools

Minitab

Job description

TALENT Software Services in Pittsburgh seeks a Medical Device Quality Engineer to support design quality activities across new product development, DFMEA, PFMEA, and design transfer readiness.

You will ensure compliance with FDA QSR and ISO 13485, participate in verification and validation planning, supplier qualification, CAPA, and problem-solving using DMAIC; bachelor's in engineering; 3+ years required.