Senior Design Quality Engineer – Medical Devices (Onsite)

Grove Technical Resources, INC; Los Angeles (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

A reputable technology consultancy in Los Angeles is seeking a Sr Quality Engineer specialized in medical devices. You will provide engineering support throughout the product development lifecycle, ensuring compliance with ISO standards and FDA regulations. The ideal candidate has substantial knowledge in regulatory matters and hands-on experience with design verification and validation. Strong analytical skills and the ability to author technical documentation are essential for this role. This position is mid-senior level and offers a contracting opportunity.

Qualifications

• 3 years of work experience in Quality Engineering.
• Detailed knowledge of FDA 21CFR 820, GMP, MDD and EU-MDR, and ISO 13485 and ISO 14971.
• Ability to author technical reports and standard operating procedures.

Responsibilities

• Provide quality engineering support throughout product development lifecycle.
• Own Risk Management (Hazards Analysis and FMEAs) across the assigned product.
• Support design verification, validation, and reliability testing.

Skills

Design Control and Regulatory Experience (ISO 13485, 21 CFR 820, EU-MDR, MDD)

Risk Management and Validation Proficiency

Implantable / Electro-Mechanical Device Experience

Education

Bachelor’s degree in engineering or science with 5+ years of work experience in Quality and/or Engineering

Master’s degree in engineering or science with 3+ years of work experience in Quality and/or Engineering

Job description

A reputable technology consultancy in Los Angeles is seeking a Sr Quality Engineer specialized in medical devices. You will provide engineering support throughout the product development lifecycle, ensuring compliance with ISO standards and FDA regulations. The ideal candidate has substantial knowledge in regulatory matters and hands-on experience with design verification and validation. Strong analytical skills and the ability to author technical documentation are essential for this role. This position is mid-senior level and offers a contracting opportunity.