Senior Quality Engineer, NPI & Supplier Excellence

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) match

PTO & Holidays

Long-term disability

Job summary

Hydrafacial is seeking a Senior Quality Engineer to lead supplier quality management and NPI quality activities. You will partner with Engineering to secure quality parts, materials, and services while guiding audits, risk management, and supplier performance across the product lifecycle.

The role combines hands-on quality engineering with strategic oversight in a hybrid Long Beach, CA setting. Strong regulatory and auditing experience is essential.

Qualifications

• Bachelor's degree in Engineering, Science, or a technical field.
• 5+ years of supplier and design control quality in the medical device industry.
• Expert knowledge of FDA 21 CFR Part 820 and ISO 13485:2016.
• Prior 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) with Engineering to ensure high reliability and quality.
• Offer technical guidance and quality compliance for Supplier Quality across the NPD lifecycle.
• Collaborate with Engineering and Supply Chain to establish Product Acceptance Sampling Strategies and Approved Supplier List coordination.
• Participate in risk management throughout the product lifecycle from development to manufacturing.
• Qualify suppliers per company standards and monitor supplier performance via metrics and SCARs.

Skills

Quality Engineering

Supplier Quality

NPI Quality

FDA 21 CFR 820

ISO 13485

Auditing

Process Validation

Statistical SPC

Vendor Management

Education

Bachelor's degree in Engineering/Science

Tools

IQ/OQ/PQ Validation

Job description

Hydrafacial is seeking a Senior Quality Engineer to lead supplier quality management and NPI quality activities. You will partner with Engineering to secure quality parts, materials, and services while guiding audits, risk management, and supplier performance across the product lifecycle.

The role combines hands-on quality engineering with strategic oversight in a hybrid Long Beach, CA setting. Strong regulatory and auditing experience is essential.