Quality Systems Engineer II - Long Beach, CAHydraFacial UK Ltd • Long Beach, CA, United States
Quality Systems Engineer II - Long Beach, CA
HydraFacial UK Ltd • Long Beach, CA, United States
1 day ago
Job type
- Full-time
Job descriptionA propos de nous Hydrafacial is a global category-creating company focused on bringing innovative products to market and delivering beauty health experiences by reinventing our consumers 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 HydraFacials 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 youll 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 : Bachelors 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 youll LOVE this role. (Base Salary Pay Range : $79,000 - $93,000 / year + bonus)An employees pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, seniority, geographic location, performance, travel requirements, revenue-based metrics, any contractual agreements, and business or organizational needs. The range listed is just one component of Hydrafacial's total rewards package for our employees. Other rewards may include annual bonuses, long-term incentives based on level, paid time off, and region-specific benefits. Come grow and GLOW with us!PERKS! Benefits include : 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), and paid holidaysHydrafacial is proud to be an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, sex, religion, sexual orientation, national origin, gender identity, gender expression, age, disability, genetic information, pregnancy or any other protected characteristic as outlined by color, federal, state or local laws. We are committed to working with and providing accommodation to applicants with physical and mental disabilities. Hydrafacial does not accept unsolicited assistance or resumes / CVs from third party search firms. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral or CV / resume submitted by a search firm to any employee at our company without a valid written search agreement. If we need additional support, we will be sure to reach out directly to one of our preferred providers. Please no phone calls or emails.Hydrafacial is a global category-creating company focused on bringing innovative products to market and delivering beauty health experiences by reinventing our consumers 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.
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