Senior Design Quality Engineer - Long Beach, CA

$93K — $120K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

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 for creating 2D drawings
  • Knowledge of FDA 21 CFR 820.30 and design control standards
  • Understanding of document control practices (ECRs, ECOs, Deviations)

Responsibilities

  • Ensure adherence to documentation practices across R&D and other departments
  • Update R&D procedures and forms to comply with current standards
  • Monitor compliance with design control documentation
  • Oversee the creation of design control documentation
  • Assist in writing key documentation including requirements, protocols, and reports
  • Organize documentation for legal team review for patents
  • Perform additional tasks as assigned

Benefits

  • Medical, dental, and vision insurance
  • Flexible spending accounts (FSAs) and health savings accounts (HSAs)
  • Accident, pet, life, and AD&D insurance provided
  • Long-term and short-term disability insurance covered by the company
  • 401(k) plan with employer match
  • Generous paid time off (PTO) and paid holidays
Full Job Description

Job Description:

The Senior Design Quality Engineer is responsible forresearch, product development, and sustaining engineering documentation.

This is a hybrid role based out of our Long Beach, CA headquarters, with designated in-office collaboration days each week.

Whatyoulldo:

Primary Responsibilities:

  • Ensure R&D and other disciplines are following good documentation practices.

  • Update existing R&D procedures and forms to align with the latest standard (FDA and ISO) and internal design practices.

  • Ensure R&D and other disciplines are following through on design control and other key documentation.

  • Manage the creation of overarching design control documentation.

  • Assistingin writing requirements, protocols, reports, and other key documentation, as well as creating CAD drawings.

  • Organize documentation captured during research and product development that will be shared with the legal team for patents.

  • Other duties asassigned.

What you need to know:

Experience/Skills/Education:

Required:

  • BS degree in Engineering or related technical field

  • 5+ years of experience in writing and leading documentation in a regulated environment

  • Experience withSolidWorks increating 2D drawings

  • Knowledge of standards for Design Controls (FDA 21 CFR 820.30) and generating andmaintainingDesign History Files (DHF)

  • Complete understanding of document control practices (ECRs, ECOs, Deviations, etc.)

Desired:

  • MS in a related technical field.

  • Lean Six Sigma

  • Strong communicationand presentation skills.

We mean it when we say youll LOVE this role.

49BBase Pay: $93,500 - $120,000 + bonus

An employees pay position within the salary range will be based on several factors, including but not limited to relevant education, qualifications, certifications, experience, skills, seniority, geographic location, performance, travel requirements, revenue-based metrics, any contractual agreements, and business or organizational needs. The range listed is just one component of HydraFacials total rewards package for our employees. Other rewards may include annual bonuses, long-term incentives based on level, paid time off, and region-specific benefits.Come grow and GLOW with us!

What else can you expect with HydraFacial?
PERKS! Benefits include: Medical insurance, dental insurance, vision insurance, FSAs, HSAs, accident insurance, pet insurance, company-paid life and AD&D insurance, company-paid long-term and short-term disability insurance, 401(k) with employer match, paid time off (PTO), and paid holidays.

#LI-Onsite

Similar Jobs

More Jobs at

More Pharmaceuticals & Biotech Jobs

Find similar Senior Design Quality Engineer - Long Beach, CA jobs: