Sr Quality Engineer

BeautyHealth • Long Beach, CA

16d • $95,000 - $115,000 • Onsite

About The Position

SkinHealth Systems' product quality begins with the quality of its suppliers and the rigor of its new product introduction process. The Senior Quality Engineer is the senior technical resource responsible for supplier quality management and New Product Introduction (NPI) quality engineering — ensuring that every new component, material, and product launch meets the clinical and regulatory quality standards that protect providers and patients. This role directly influences what gets built, how it is validated, and whether it reaches market at the standard SkinHealth Systems demands.

Requirements

• Bachelor's degree in Engineering, Science, or a technical field or equivalent work experience.
• 5+ years of experience in 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.
• Effective verbal and written communication skills with ability to interface with internal stakeholders and suppliers.

Nice To Haves

• ASQ Certified Quality Engineer (CQE) or Certified Supplier Quality Professional (CSQP).
• Prior experience with cosmetics, consumables, or pharmaceuticals.
• Experience with statistical process control and sampling methodologies (ANSI/ASQ Z1.4, Z1.9).

Responsibilities

• Provide Pre-Market Quality Engineering support to New Product Development (NPD), working in partnership with Engineering to deliver quality parts, materials, and services that prevent defects and meet the highest reliability standards.
• Provide technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle — from newly qualified parts through implementing strategies for driving product quality and continuous improvement.
• Collaborate with Engineering and Supply Chain to develop and deliver Product Acceptance Sampling Strategies, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
• Participate in risk management activities throughout the product lifecycle from development through manufacturing.
• Qualify suppliers according to company standards; ensure that suppliers deliver quality parts, materials, and services.
• Monitor parts from acquisition through the manufacturing cycle; communicate and resolve supplier-related problems as they arise.
• Develop and prioritize an auditing schedule to ensure designated suppliers are audited regularly against GMP and, quality standards, and contractual agreements.
• Evaluate suppliers' internal functions to assess overall performance; provide feedback on their quality management practices.
• Trend and monitor supplier performance using statistical data including NCMRs, Supplier Corrective Action Requests (SCARs), and scrap metrics.
• Ensure purchased products and components are manufactured and qualified in accordance with applicable industry standards, regulatory requirements, and customer requirements.
• Perform other duties as assigned.

Benefits

• 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)
• paid holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Senior