Senior Quality Engineer, Medical Devices (EU-MDR) – Hybrid

Radiant Systems Inc; Mahwah (NJ); Hybrid; USD 83,000 - 90,000; Full time

Job summary

Major Medical Device Client is seeking a Manufacturing Senior Quality Assurance Engineer to join our hybrid team in Mahwah, NJ. You will lead quality assurance activities for EU-MDR initiatives, develop process controls, and collaborate with design, manufacturing engineering, and project managers to ensure regulatory compliance and defect-free products.

The role emphasizes PPAP/FAI execution, change management, and supporting SOP updates in a fast-paced manufacturing setting.

Qualifications

• Bachelor’s degree in Biomedical or Mechanical Engineering.
• 4+ years of relevant industry experience.
• Experience supporting EU-MDR programs and initiatives.

Responsibilities

• Develop, execute, and approve FAI strategies.
• Support PPAP activities and change control.
• Review SOPs and risk documentation updates.
• Review and approve FAI and related inspections (FAI).
• Collaborate with cross‑functional teams on deliverable updates and project strategy.
• Provide quality engineering support for EU-MDR initiatives across product portfolio.

Skills

Problem solving

Decision making

EU-MDR

Education

Biomedical/Mechanical Eng

Job description

Major Medical Device Client is seeking a Manufacturing Senior Quality Assurance Engineer to join our hybrid team in Mahwah, NJ. You will lead quality assurance activities for EU-MDR initiatives, develop process controls, and collaborate with design, manufacturing engineering, and project managers to ensure regulatory compliance and defect-free products.

The role emphasizes PPAP/FAI execution, change management, and supporting SOP updates in a fast-paced manufacturing setting.