Senior Quality Engineer NPI & Supplier Quality

HydraFacial Germany GmbH; Long Beach, Northern (CA, KY); Hybrid; USD 95,000 - 115,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

FSAs/HSAs

Life and AD&D insurance

401(k) with employer match

Paid time off

Job summary

Hydrafacial is seeking a Senior Quality Engineer in Long Beach, CA to lead supplier quality and NPI quality activities. You will guide quality across the NPD lifecycle, qualify suppliers, and drive product quality with risk management and SQA collaboration across engineering and supply chain.

Responsibilities include establishing sampling strategies, auditing suppliers against GMP, and monitoring performance with SCARs and NCMRs. Strong communication with internal teams is essential.

Qualifications

• 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.
• 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.
• Excellent verbal and written communication with internal stakeholders and suppliers.

Responsibilities

• Provide Pre-Market Quality Engineering support to New Product Development (NPD) in partnership with Engineering.
• Provide technical guidance for Supplier Quality engagement throughout the NPD lifecycle.
• Develop and deliver Product Acceptance Sampling Strategies and Supplier List coordination.
• Participate in risk management activities across the product lifecycle.
• Qualify suppliers and ensure they deliver quality parts and services.
• Audit scheduling to ensure GMP and contractual compliance.
• Trend and monitor supplier performance using NCMRs, SCARs, and scrap metrics.

Skills

Supplier quality management

GMP/ISO quality standards

FDA 21 CFR Part 820

Lead Auditor experience

Process validation

Verbal and written communication

Statistical process control

Education

Bachelor's degree in Engineering/Science/Technical field

Job description

Hydrafacial is seeking a Senior Quality Engineer in Long Beach, CA to lead supplier quality and NPI quality activities. You will guide quality across the NPD lifecycle, qualify suppliers, and drive product quality with risk management and SQA collaboration across engineering and supply chain.

Responsibilities include establishing sampling strategies, auditing suppliers against GMP, and monitoring performance with SCARs and NCMRs. Strong communication with internal teams is essential.