Medical Device Quality Engineer — Onsite & Impact

Yoh,-A-Day-; Redondo Beach (CA); On-site; USD 469,000 - 6,750,000; Full time

Benefits offered by this job

Medical benefits

401K Retirement Savings Plan

Direct Deposit & weekly payroll

Employee assistance program

Job summary

Yoh is seeking a Quality Engineer in Redondo Beach, CA to support product and manufacturing quality through inspection and testing strategies, defect analysis, statistical methods, and continuous improvement. You will work with Development, Product, Manufacturing, and Quality teams to ensure compliance with ISO 13485 and EU standards in a regulated environment.

The role requires a Bachelor's in Engineering (Master's preferred) and strong analytical/problem-solving skills, with knowledge of SQL

Qualifications

• Bachelor's degree in Engineering required; Master's preferred.
• Experience in Quality Assurance in a regulated environment is required.
• Knowledge of ISO 13485 and applicable EU standards; MDR experience is a plus.
• SQL and scripting skills; strong analytical problem-solving abilities.

Responsibilities

• Review product specifications and ensure quality objectives.
• Develop inspection and testing methods for product and equipment.
• Perform statistical analyses to identify nonconformities.
• Document quality results and support documentation control.
• Collaborate with Development, Product, Manufacturing, and Quality teams.

Skills

Analytical thinking

Problem solving

Communication skills

Regulatory knowledge

SQL

Scripting

MS Office

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Professional certifications

10+ years of equivalent experience

Tools

SQL

Scripting

Microsoft Office

Job description

Yoh is seeking a Quality Engineer in Redondo Beach, CA to support product and manufacturing quality through inspection and testing strategies, defect analysis, statistical methods, and continuous improvement. You will work with Development, Product, Manufacturing, and Quality teams to ensure compliance with ISO 13485 and EU standards in a regulated environment.

The role requires a Bachelor's in Engineering (Master's preferred) and strong analytical/problem-solving skills, with knowledge of SQL