Quality Systems Engineer I

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 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. We collaborate with every department, focused on enhancing efficiency and ensuring satisfaction for both internal and external customers to ensure product quality, regulatory compliance and document control. 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 review and manage MRB/NCMR activities, moving items electronically and physically as required. Grand Avenue Software (GAS) experience is a must.
• You will coordinate with cross-functional teams, Manufacturing, Engineering, Supply Chain, and Regulatory Affairs, regarding investigations, dispositions, and implementation activities.
• You will review nonconformance records for completeness, accuracy, and compliance, and support users with quality system questions and troubleshooting.
• You will track, report, and trend nonconformance metrics, reviewing aging/open NCMRs and escalating as necessary.
• You will schedule and host MRB meetings, generate and review quality metrics/KPIs, and review trends related to nonconformances, supplier issues, and product lines.
• You will support the update, validation, and verification of electronic systems.
• You will lead and implement automations within existing systems to streamline workflows.
• Automation experience with Zapier and Botable is a must; you will design, build, and maintain automated workflows using these platforms.
• You will support updates to procedures, forms, and work instructions, and other QMS-related activities as needed.
• You will support internal and external audits, review process effectiveness, and assist with implementation or validation activities related to quality systems and processes.
• You will support Management Review and Post-Market Surveillance reporting, external audit preparation, and periodic review/update of controlled documents and quality records.
• You will 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
• 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 30 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 with spreadsheets, documents, electronic systems. 

Note: The Company utilizes the multi-skill concept and expects the employee to perform other job disciplines Nothing in this job specification restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Critical features of this job are described under various headings above. They may be subject to change at any time due to reasonable accommodation or other reasons. The above statements are strictly intended to describe the general nature and level of the work being performed. They are not intended to be construed as a complete list of all responsibilities, duties, and skills required of employees in this position.

Notice to Staffing Agencies and Search Firms:

RxSight does not accept unsolicited resumes or candidate submissions from staffing agencies or search firms for any employment opportunities. All agency engagements must be authorized in writing for a specific position by RxSight’s Talent Acquisition department. Any resumes or candidate information submitted without such specific engagement will be considered unsolicited and the property of RxSight. No fees will be paid in the event a candidate is hired under these circumstances.