Senior Design Quality Engineer - Regulation & DHF Lead

HydraFacial Germany GmbH; Long Beach (CA); Hybrid; USD 93,500 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with employer match

Paid time off

Paid holidays

Job summary

HydraFacial Germany GmbH in Long Beach, CA is seeking a Senior Design Quality Engineer to drive regulatory-compliant design and development documentation across R&D. You will update procedures to FDA/ISO standards, create design control artifacts, and collaborate with cross-functional teams to ensure DHF integrity and file patents with the legal team.

You will mentor teams in documentation best practices and contribute to continuous quality improvements across product development cycles.

Qualifications

• BS degree in Engineering or related technical field.
• 5+ years of experience writing and leading documentation in a regulated environment.
• Experience with SolidWorks for 2D drawings.
• Knowledge of Design Controls standards (FDA 21 CFR 820.30) and DHF management.
• 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 FDA/ISO standards and internal design practices.
• Ensure design controls and key documentation are followed through.
• Manage creation of overarching design control documentation.
• Assist in writing requirements, protocols, reports, and create CAD drawings.
• Organize documentation for patents and share with legal team.

Education

Bachelor's degree in Engineering or related technical field

MS in a related technical field

Tools

SolidWorks

Job description

HydraFacial Germany GmbH in Long Beach, CA is seeking a Senior Design Quality Engineer to drive regulatory-compliant design and development documentation across R&D. You will update procedures to FDA/ISO standards, create design control artifacts, and collaborate with cross-functional teams to ensure DHF integrity and file patents with the legal team.

You will mentor teams in documentation best practices and contribute to continuous quality improvements across product development cycles.