Quality Engineer – Regulated Medical Devices

JobDiva, Inc.; Chicago (IL); On-site; USD 85,000 - 120,000; Full time

Job summary

JobDiva, Inc. in Chicago seeks a Quality Engineer to ensure compliance with FDA/ISO standards and to support manufacturing quality across the product lifecycle.

You will lead validation activities, manage DHR deliverables, participate in risk management, and drive QMS improvements while collaborating with design, manufacturing, and regulatory teams. Requirements include a bachelor's or master's in engineering or science, 3+ years in regulated industries, and proficiency with FMEA, DOE, and Gage

Qualifications

• Bachelor's or Master's degree in Engineering, Science, or related field.
• 3+ years of quality experience in regulated industries (pharma/medical devices).
• Working knowledge of FDA 21 CFR 820 and ISO 13485.
• Experience leading validation and documentation in manufacturing.

Responsibilities

• Support and challenge the project team on quality.
• Review and approve quality docs per procedures.
• Lead validation activities and ensure DHR deliverables.
• Participate in risk management using RM Plan/Report and FMEA.
• Report project status to Unit Quality Manager.
• Participate in internal audits.
• Maintain and improve the QMS.
• Ensure program and product traceability.

Skills

Quality engineering

Regulatory compliance

Communication

Organizational skills

Education

Bachelor's or Master's in Engineering/Science

Tools

Gage R&R

Design of Experiments

FMEA

Job description

JobDiva, Inc. in Chicago seeks a Quality Engineer to ensure compliance with FDA/ISO standards and to support manufacturing quality across the product lifecycle.

You will lead validation activities, manage DHR deliverables, participate in risk management, and drive QMS improvements while collaborating with design, manufacturing, and regulatory teams. Requirements include a bachelor's or master's in engineering or science, 3+ years in regulated industries, and proficiency with FMEA, DOE, and Gage