Hydrafacial is looking to maintain, improve, and leverage its Quality Management System (QMS) to ensure compliance with international standards and regulatory requirements, drive continuous improvement, and enhance product and process quality.
Requirements
- Familiarity with ISO 13485, MDSAP, and other applicable regulatory frameworks (e.g., FDA QSR, UKCA).
- Experience with quality system processes such as NCMR, CAPA, Complaint Handling, and Change Control.
- Experience with MasterControl or similar EQMS platform.
- Proficiency in Power BI, Excel (pivot tables, formulas), and data visualization techniques.
- Experience developing and maintaining dashboards for reporting quality KPIs.
- Experience with data cleaning, DAX/Power Query, or other analytics tools.
- Understanding of system administration functions in MasterControl (e.g., role management, template configuration, document lifecycle).
Responsibilities
- Investigate and close Non-Conformance Reports (NCRs), identify root causes, and implement corrective and preventive actions (CAPAs).
- Investigate and resolve customer complaints, ensuring timely response, resolution, and quality improvements.
- Conduct internal audits to assess compliance with ISO 13485:2016, MDSAP, and applicable regulatory requirements.
- Lead and support continuous improvement initiatives across the QMS.
- Maintain and report on key quality metrics (e.g., CAPA, NCMR, Customer Complaints, Deviations, and Change Control).
- Build and maintain dashboards and reports to communicate quality performance and trends to leadership.
- Serve as the system administrator for MasterControl, managing user roles, workflows, training records, and system updates.
Other
- Bachelor’s degree in a relevant field (Engineering, Life Sciences, or similar) or equivalent experience.
- 0–2 years of experience in a regulated industry (Medical Device experience a plus).
- Strong communication, organization, and problem-solving skills.
- Passion for continuous improvement and enabling process efficiency through systems and data.
- This is a hybrid position based in Long Beach, CA, requiring days in-office and remote each week.
