Senior Design Quality Engineer - Regulated Documentation

beautyhealth; Long Beach (CA); On-site; USD 94,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

FSAs

HSAs

Accident insurance

Pet insurance

Life and AD&D insurance

Long-term disability insurance

Short-term disability insurance

401(k) with employer match

PTO

Paid holidays

Job summary

Hydrafacial is seeking a Senior Design Quality Engineer to lead documentation and design control activities across R&D and manufacturing. This role focuses on FDA/ISO DHF creation, design history files, and ensuring compliant processes.

You will collaborate with cross-functional teams to update procedures, write requirements, and generate CAD drawings while supporting patent-ready documentation and regulatory readiness. On-site in Long Beach.

Qualifications

• BS degree in Engineering or related technical field.
• 5+ years of experience in writing and leading documentation in a regulated environment.
• Experience with SolidWorks in creating 2D drawings.
• Knowledge of Design Controls (FDA 21 CFR 820.30) and Design History Files (DHF).
• Understanding of document control practices (ECRs, ECOs, Deviations).

Responsibilities

• Ensure R&D and other disciplines follow good documentation practices.
• Update R&D procedures and forms to align with FDA/ISO standards and internal design practices.
• Ensure design control and key documentation are properly followed.
• Assist in writing requirements, protocols, reports, and CAD drawings.
• Organize research and development documentation for patent sharing.

Skills

Documentation writing

Regulated environment experience

Communication skills

Education

BS in Engineering or related field

Tools

SolidWorks

Job description

Hydrafacial is seeking a Senior Design Quality Engineer to lead documentation and design control activities across R&D and manufacturing. This role focuses on FDA/ISO DHF creation, design history files, and ensuring compliant processes.

You will collaborate with cross-functional teams to update procedures, write requirements, and generate CAD drawings while supporting patent-ready documentation and regulatory readiness. On-site in Long Beach.