Senior Quality Engineer - Supplier & NPI (Med Device)

Hydrafacial LLC.; Long Beach (CA); Hybrid; USD 95,000 - 115,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with employer match

Paid time off

Job summary

Hydrafacial LLC is seeking a Sr. Quality Engineer in Long Beach, CA, hybrid work arrangement. You will lead supplier quality activities and NPI quality engineering to ensure that new components and products meet FDA/ISO quality standards.

The role requires 5+ years in medical device quality and a track record as a Lead Auditor. You will drive risk management, supplier audits, and quality improvements across the product lifecycle.

Qualifications

• Bachelor's degree in Engineering, Science, or a technical field.
• 5+ years of supplier and design control quality in medical devices.
• Expert knowledge of FDA 21 CFR Part 820 and ISO 13485:2016.
• Lead Auditor or Auditor experience.
• Experience with Process Validations and/or Test Method Validations (IQ, OQ, PQ, and/or TMV).
• Strong knowledge of supplier quality management techniques and best practices.

Responsibilities

• Provide Pre-Market Quality Engineering support to New Product Development (NPD).
• Provide quality compliance for Supplier Quality throughout the NPD lifecycle.
• Collaborate with Engineering and Supply Chain on Product Acceptance Sampling Strategies and Supplier QA deployment.
• Participate in risk management activities from development through manufacturing.
• Qualify suppliers and ensure quality parts, materials, and services.
• Monitor supplier performance using NCRs/SCARs and scrap metrics.

Skills

Supplier quality management

Quality engineering

Verbal communication

Written communication

Statistical methods

Education

Bachelor's degree in Engineering/Science/Technical field

Tools

IQ/OQ/PQ

Job description

Hydrafacial LLC is seeking a Sr. Quality Engineer in Long Beach, CA, hybrid work arrangement. You will lead supplier quality activities and NPI quality engineering to ensure that new components and products meet FDA/ISO quality standards.

The role requires 5+ years in medical device quality and a track record as a Lead Auditor. You will drive risk management, supplier audits, and quality improvements across the product lifecycle.