Quality Systems Specialist

About the role

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.

Responsibilities

• Develop a comprehensive understanding of all our products and devices while collaborating with cross-functional teams to ensure business continuity.
• 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.
• 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.
• Manage internal and external preventative maintenance (PM) activities, working closely with equipment owners to keep PM intervals, procedures, and manufacturer documentation current.
• Track and manage equipment events, including Out-of-Tolerance (OOT) conditions, Planned Events, and Unplanned Maintenance, driving each to closure.
• Manage equipment assigned to Field Service Engineers (FSEs), coordinating replacement shipments and returns so FSEs always have current, calibrated, active equipment in the field.
• 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.
• Support quarterly equipment walkthroughs and Equipment Event Log reviews, identifying and driving correction of labeling, documentation, or compliance gaps.
• 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.
• Be challenged to find innovative and creative ways to improve and streamline systems and processes as our company grows.
• Assist with internal and external audits.
• Ensure compliance with Quality standards, including monitoring regulatory updates.

Requirements

• 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

Education, Experience, And Training

• Minimum of Bachelor’s Degree and 2 years of relevant work experience.
• 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.

Salary

$85,000 To $100,000 Per Year