Senior Design Quality Engineer - Regulated Docs & DHF

Hydrafacial; 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

Life and AD&D insurance

Short/long-term disability insurance

401(k) with employer match

Paid time off

Paid holidays

Job summary

HydraFacial is seeking a Senior Design Quality Engineer to lead documentation efforts in a regulated environment. You will drive design controls, maintain the Design History File, and assist in writing requirements, protocols and reports while creating CAD drawings in SolidWorks.

You will update procedures to reflect current FDA/ISO standards, coordinate with R&D, and organize documentation for patent activities. Strong communication and cross-functional collaboration are essential.

Qualifications

• BS degree in Engineering or related technical field.
• 5+ years of experience in writing and leading documentation in a regulated environment.
• Knowledge of FDA 21 CFR 820.30 Design Controls and DHF.
• Experience with SolidWorks for 2D drawings.

Responsibilities

• Ensure R&D and other disciplines follow good documentation practices.
• Update R&D procedures and forms to align with FDA/ISO and internal design practices.
• Manage creation of overarching design control documentation and DHF.
• Assist in writing requirements, protocols, reports and other key documentation, and create CAD drawings.
• Organize documentation for patent sharing with the legal team.
• Other duties as assigned.

Skills

Documentation leadership

Regulated environment experience

Design Controls

Document control

Cross-functional collaboration

Education

BS in Engineering or related field

MS in related technical field

Tools

SolidWorks

Job description

HydraFacial is seeking a Senior Design Quality Engineer to lead documentation efforts in a regulated environment. You will drive design controls, maintain the Design History File, and assist in writing requirements, protocols and reports while creating CAD drawings in SolidWorks.

You will update procedures to reflect current FDA/ISO standards, coordinate with R&D, and organize documentation for patent activities. Strong communication and cross-functional collaboration are essential.