Quality Systems Engineer I

Overview

As the Quality Systems Engineer, you will own the day-to-day operation of RxSight's Nonconforming Material Report (NCMR) and Material Review Board (MRB) program, coordinating investigations, dispositions, and closure activities across Manufacturing, Engineering, Supply Chain, and Regulatory Affairs.

Essential Duties and Responsibilities

• Review and manage MRB/NCMR activities, moving items electronically and physically as required; Grand Avenue Software (GAS) experience is a must.
• Coordinate with cross-functional teams (Manufacturing, Engineering, Supply Chain, Regulatory Affairs) regarding investigations, dispositions, and implementation activities.
• Review nonconformance records for completeness, accuracy, and compliance, and support users with quality system questions and troubleshooting.
• Track, report, and trend nonconformance metrics, reviewing aging/open NCMRs and escalating as necessary.
• Schedule and host MRB meetings, generate and review quality metrics/KPIs, and review trends related to nonconformances, supplier issues, and product lines.
• Support the update, validation, and verification of electronic systems.
• Lead and implement automations within existing systems to streamline workflows.
• Design, build, and maintain automated workflows using Zapier and Botable.
• Support updates to procedures, forms, and work instructions, and other QMS-related activities as needed.
• Support internal and external audits, review process effectiveness, and assist with implementation or validation activities related to quality systems and processes.
• Support Management Review and Post-Market Surveillance reporting, external audit preparation, and periodic review/update of controlled documents and quality records.
• Support continuous improvement initiatives and system enhancements across the quality organization.

Required Knowledge, Skills and Abilities

• Strong working knowledge of nonconforming material control, MRB disposition processes, and root cause investigation.
• Proficiency in Microsoft Word, Excel, Smartsheet, Power BI, and other quality management software systems.
• Hands-on automation experience with Zapier and Botable.
• Experience with Grand Avenue Software.
• Working knowledge of ISO 13485, 21 CFR 820, 21 CFR Part 11 as they relate to nonconformance handling.
• Basic knowledge of quality system and device requirements in the US, EU, Mexico, Canada, Australia, Brazil, Japan, and other markets.
• Curious mindset with a strong sense of integrity, accountability, and commitment to service.
• Detail-oriented individual capable of evaluating engineering justifications, product impact analyses, and risk assessments supporting MRB dispositions.
• Excellent interpersonal, computer, communication, and presentation skills.
• Self-starter able to succeed in an unstructured environment.
• Excellent teamwork skills with proven ability to collaborate across Manufacturing, Engineering, Supply Chain, and Regulatory Affairs, and to influence MRB stakeholders without formal authority.

Education, Experience, and Training

• Minimum of Bachelor's Degree and 3+ years of relevant quality engineering/nonconformance experience, or equivalent combination of education and experience.
• Microsoft Word; Microsoft Excel.
• Experience with an electronic nonconformance/MRB system (Grand Avenue Software or equivalent) and QAD (ERP) a plus.
• Proficiency 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.
• Training requirements on Insider Trading Policy, Global Anti-Bribery and Anti-Corruption Policy, and Code of Business Conducts and Ethics must be completed within 30 days from the hiring date and on an annual basis.

Certificates, Licenses, Registrations

ASQ certification or CQE recommended but not required.