NPI Quality Engineer — Med Device | Design Controls & Validation

SaniSure; Camarillo (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

SaniSure in Camarillo, California is seeking an NPI Quality Engineer to ensure quality and regulatory compliance during new product development. The role involves cross-functional collaboration and responsibilities for design validation and manufacturing readiness.

The ideal candidate will hold a Bachelor’s degree in a relevant field and have at least 3 years of experience in medical device quality engineering, alongside strong documentation skills and knowledge of FDA regulations.

Qualifications

• Minimum 3 years of experience in medical device quality engineering.
• Experience with FDA 21 CFR Part 820 (QSR), ISO 13485, and Design Controls.
• Strong technical documentation skills.

Responsibilities

• Ensure compliance with regulatory requirements during product development.
• Drive improvements in NPI processes and support CAPA investigations.
• Lead or support risk management activities per ISO 14971.

Skills

Quality engineering

Regulatory compliance

Statistical analysis

Cross-functional teamwork

Education

Bachelor’s degree in biological sciences, engineering, or a related field

Job description

SaniSure in Camarillo, California is seeking an NPI Quality Engineer to ensure quality and regulatory compliance during new product development. The role involves cross-functional collaboration and responsibilities for design validation and manufacturing readiness.

The ideal candidate will hold a Bachelor’s degree in a relevant field and have at least 3 years of experience in medical device quality engineering, alongside strong documentation skills and knowledge of FDA regulations.