Senior QA Engineer — Hybrid Med Device & QMS

Judge Group, Inc.; Mahwah (NJ); Hybrid; USD 104,000 - 131,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Hybrid work arrangement

Job summary

Judge Group, Inc. seeks a Senior Engineer, Quality Assurance for a 12-month+ contract in Mahwah, NJ. The role provides QA support across QA activities, including FAI strategy, PPAP, change control, validation, SOP and risk management, with cross-functional collaboration.

Hybrid role with on-site presence required. Requirements include a Bachelor’s in Biomedical/Mechanical Engineering, 4+ years’ experience, EU-MDR knowledge, ISO 13485/GDP/GMP familiarity, and strong MS Word/Excel/PowerPoint

Qualifications

• Bachelor’s degree in engineering or related field.
• 4+ years of industry experience.
• Experience with EU-MDR programs and quality systems.

Responsibilities

• Lead/advise on First Article Inspection (FAI) strategy and approvals.
• Manage PPAP and change control processes and assessments.
• Validate equipment and processes; maintain SOP and risk documentation.
• Collaborate with cross-functional teams to improve quality performance.

Skills

Quality assurance

QA engineering

Process control

Education

Bachelor’s Degree in Engineering

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Judge Group, Inc. seeks a Senior Engineer, Quality Assurance for a 12-month+ contract in Mahwah, NJ. The role provides QA support across QA activities, including FAI strategy, PPAP, change control, validation, SOP and risk management, with cross-functional collaboration.

Hybrid role with on-site presence required. Requirements include a Bachelor’s in Biomedical/Mechanical Engineering, 4+ years’ experience, EU-MDR knowledge, ISO 13485/GDP/GMP familiarity, and strong MS Word/Excel/PowerPoint