Senior Design Quality Engineer — Regulated Docs & DHF Lead

Hydrafacial LLC; Long Beach (CA); Hybrid; USD 93,500 - 112,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with employer match

Paid time off (PTO)

Job summary

Hydrafacial LLC in Long Beach, CA is seeking a Senior Design Quality Engineer responsible for R&D processes and documentation. The role requires a BS in Engineering, 5+ years in a regulated environment, and proficiency in SolidWorks.

Benefits include medical and dental insurance, paid time off, and a 401(k) with employer match. The salary range for this position is between $93,500 and $112,000 plus bonuses.

Qualifications

• 5+ years of experience in writing and leading documentation in a regulated environment.
• Experience with SolidWorks creating 2D drawings.
• Knowledge of standards for Design Controls and generating and maintaining Design History Files.

Responsibilities

• Ensure R&D is following good documentation practices.
• Update R&D procedures to align with latest standards.
• Manage the creation of overarching design control documentation.

Skills

Writing and leading documentation in a regulated environment

SolidWorks

Design Controls (FDA 21 CFR 820.30)

Document control practices

Education

BS degree in Engineering or related technical field

MS in a related technical field

Tools

CAD

SolidWorks

Job description

Hydrafacial LLC in Long Beach, CA is seeking a Senior Design Quality Engineer responsible for R&D processes and documentation. The role requires a BS in Engineering, 5+ years in a regulated environment, and proficiency in SolidWorks.

Benefits include medical and dental insurance, paid time off, and a 401(k) with employer match. The salary range for this position is between $93,500 and $112,000 plus bonuses.