Quality Systems Specialist

Description RxSight® is an ophthalmic medical technology corporation headquartered in Aliso Viejo, California that has commercialized the world’s first and only adjustable intraocular lens (IOL) that is customized after cataract surgery. The company’s mission is to revolutionize the premium cataract surgery experience by allowing surgeons to partner with their patients to achieve optimized results for every unique eye.

OVERVIEW:

Being part of the Quality Systems & Compliance team means you are joining a team that wears many hats. As the Quality Systems Specialist – Equipment Management, you will own the day-to-day administration of RxSight's Equipment Management program, from new equipment intake through calibration/PM scheduling, event tracking, and equipment retirement. You will work closely with equipment owners across R&D, Manufacturing, Facilities, and Field Service to keep every piece of equipment identified, current, and audit-ready. Whether you're an experienced Quality professional or seeking a fresh opportunity, we invite you to join our dynamic and expanding team! Requirements

ESSENTIAL DUTIES AND RESPONSIBILITIES:

You will develop a comprehensive understanding of all our products and devices while collaborating with cross-functional teams to ensure business continuity. You will own the full equipment lifecycle from new equipment intake, Out-of-Service tagging, and Equipment ID# assignment review and activation, working closely with designated department equipment owners. You will schedule and coordinate all calibration activities, working with equipment owners, approved external calibration providers, and original equipment manufacturers to ensure no equipment is used with an overdue CAL/PM. You will manage internal and external preventative maintenance (PM) activities, working closely with equipment owners to keep PM intervals, procedures, and manufacturer documentation current. You will track and manage equipment events, including Out-of-Tolerance (OOT) conditions, Planned Events, and Unplanned Maintenance, driving each to closure. You will manage equipment assigned to Field Service Engineers (FSEs), coordinating replacement shipments and returns so FSEs always have current, calibrated, active equipment in the field. You will review, verify, and file all calibration, PM, and qualification (IQ/OQ/PQ) records and other equipment documentation into the appropriate equipment files, ensuring completeness and accuracy. You will support quarterly equipment walkthroughs and Equipment Event Log reviews, identifying and driving correction of labeling, documentation, or compliance gaps. You will collaborate cross-functionally with R&D, Manufacturing, Facilities, and Technical Service to ensure equipment status changes, CAL/PM extensions, and OOT/product impact assessments are properly documented and escalated. You will be challenged to find innovative and creative ways to improve and streamline systems and processes as our company grows. You will assist with internal and external audits. You will ensure compliance with Quality standards, including monitoring regulatory updates.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

Working knowledge of equipment/asset management systems (xTrak or equivalent) and calibration/PM programs preferred Knowledge of ISO 13485, 21 CFR 820, and 21 CFR Part 11 as they relate to control of monitoring and measuring equipment Proficiency in Microsoft Word, Excel, Smartsheet, Power BI, and equipment/asset management databases (xTrak preferred) Detail-oriented individual capable of tracking calibration/PM due dates, OOT conditions, and equipment records across a large, multi-department equipment inventory Strong teamwork and communication skills to coordinate with equipment owners, Field Service Engineers, department managers, and outside calibration/PM vendors Strong adaptability and flexibility to handle daily changes

SUPERVISORY RESPONSIBILITIES:

None EDUCATION, EXPERIENCE, and TRAINING: Minimum of Bachelor’s Degree and 2 years of relevant work experience. Microsoft Word; Microsoft Excel Experience with an equipment/asset management system (xTrak or equivalent) and calibration/PM scheduling a plus Proficient with Microsoft office tools Good decision-making, organization skills, problem-solving skills, and teamwork oriented Training to be completed per the training plan for this position as maintained in the document control system. The training requirements on TRN-10007 Insider Trading Policy, TRN-10008 Global Anti-Bribery and Anti-Corruption Policy and TRN-10009 Code of Business Conducts and Ethics must be diligently completed within 15 days from the hiring date and on an annual basis.

CERTIFICATES, LICENSES, REGISTRATIONS:

ASQ certification or CQE recommended but not required

COMPUTER SKILLS:

You will be working within spreadsheets, documents, electronic systems #J-18808-Ljbffr RxSight