Quality Systems Engineer II - Long Beach, CA

About Us

Hydrafacial is a global category-creating company focused on bringing innovative products to market and delivering beauty health experiences by reinventing our consumer’s relationship with their skin, their bodies and their self-confidence.

Every person here is a key player in our success.  We are firm believers in making the little things count each day so the big things will follow. If this sounds like you, come check us out! This is the perfect opportunity to work with some of the best leaders in the industry while you gain the global and strategic experience to add to your professional toolbox.
 

Job Description:

The Quality Systems Engineer II is a key contributor to HydraFacial’s Quality Management System (QMS), supporting compliance, process excellence, and continuous improvement across all quality functions. This role is designed for an experienced quality professional with 5+ years in regulated industries who can independently lead system initiatives, validations, data analysis, and root cause investigations. You will work cross-functionally to optimize processes, ensure compliance with global standards, and provide actionable insights through quality metrics and reporting. 
 

What you’ll do: 

Primary Responsibilities:  

• Support all aspects of QMS processes, including CAPA, complaint handling, deviations, change control, document control, and risk management. 

• Lead and support validation efforts (software, equipment, and processes), ensuring compliance with ISO 13485, FDA QSR, MDSAP, and EU MDR. 

• Assist in internal audits and participate in external inspections, ensuring audit readiness across the organization. 

• Develop and improve procedures, workflows, and system processes to enhance compliance, efficiency, and scalability. 

• Analyze complaints, NCRs, and other quality events to identify root causes and systemic trends. 

• Build and maintain data sets and dashboards (Power BI/Excel or similar) to track and trend key quality processes. 

• Provide leadership with data-driven insights to support decision-making, risk assessment, and strategic planning. 

• Collaborate with R&D, Operations, Regulatory, and Customer Care to improve processes and resolve systemic quality issues. 

• Partner with IT and system owners to support data analytics. 

• Contribute to a culture of quality and continuous improvement throughout the organization. 

What you need to know: 

Experience/Skills/Education: 

Required: 

• Bachelor’s degree in Engineering, Life Sciences, or related field. 

• 5+ years of quality experience in a regulated industry (medical device preferred). 

• Strong knowledge of Quality System Elements 

• Hands-on experience with QMS processes (CAPA, complaints, validation, internal audits, change control, etc.). 

• Demonstrated skill in analyzing quality data, building reports, and communicating trends. 

Desired 

• Proficiency in Power BI, advanced Excel, and data visualization. 

• Experience with eQMS platforms (MasterControl strongly preferred). 

• Familiarity with EU MDR, UKCA, 21 CFR 820, ISO 13485 and international regulatory requirements. 

• Strong communication, collaboration, and leadership skills. 

We mean it when we say you’ll LOVE this role.

(Base Salary