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Quality Assurance and Calibration Program Manager

2 months ago

Aliso Viejo, California, United States RXSIGHT INC Full time
Job Description

RxSight Inc. is a leading ophthalmic medical technology corporation that has commercialized the world's first and only adjustable intraocular lens (IOL) that is customized after cataract surgery. Our 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.

**Key Responsibilities:**

  • Assist in equipment calibration program and LDD RMAs to ensure compliance with regulatory requirements.
  • Support equipment qualifications and re-qualifications, as needed, to maintain quality and safety standards.
  • Coordinate with equipment owners and suppliers to troubleshoot and resolve equipment issues.
  • Support equipment and process validations to ensure product quality and regulatory compliance.
  • Work with Product Development, Manufacturing, and Quality Control departments to ensure product quality and regulatory compliance.
  • Perform quality functions to support ISO 13485, FDA, CGMP, Quality System Regulations, management reporting, production/QA/QC, process development, manufacturing transfer, and facility support as required.
  • Provide support during audits to ensure compliance with regulatory requirements.

**Requirements:**

  • **Essential Duties and Responsibilities:**
  • Monitor and maintain laboratory and engineering equipment to ensure preventive maintenance and calibration program compliance, including budgets and POs.
  • Update equipment processes to ensure compliance with latest requirements and to streamline processes wherever possible.
  • Review and understand quality regulations for audits, compliance, and implementation.
  • Revised and format Quality System controlled documentation, including procedures, forms, and engineering documents.
  • Support validations, perform testing, and update QA/QC/process documentation.
  • Provide support in updating MVP and the associated documents.
  • Co-Owner of DicksonOne system and all associated loggers.
  • Co-Owner of XTrak system with USCalibration.
  • Monitor and maintain the environmental monitoring program for the cleanrooms.
  • Other administrative duties as required, including printing labels, maintaining logbooks, maintaining environmental logbooks, etc.
  • Establish and maintain document control practices for the manufacturing area including batch records, data systems, and material release.
  • Review test results and release material for use.
  • Responsible for assisting the Quality Assurance team with any ad hoc reports and assignments as required.
  • Perform in-process, final, or incoming inspections as required.
  • Reviews LDD Batch Records.
  • Supports RMA-LDD.
  • Write and review material review board dispositions within the functional area.
  • Maintain working knowledge of all U.S. and International standards relating to medical devices including biocompatibility, physicochemical, optical mechanical, IEC/EMC, ISO, etc. for the company as required.
  • Other responsibilities as defined by the Senior Quality Operations Manager- LDD.

**Required Knowledge, Skills, and Abilities:**

  • Knowledgeable of equipment and calibration of equipment.
  • Knowledgeable of 21 CFR 820, 21 CFR 807, 21 CFR 806, and 21 CFR Part 11.
  • Knowledgeable of ISO 13485.

**Supervisory Responsibilities:**

  • None.

**Education, Experience, and Training:**

  • Bachelor's degree or a combination of education and experience.
  • Microsoft Word; Microsoft Excel.
  • QAD experience a plus.
  • 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 recommended but not required.

**Computer Skills:**

  • Competent in use of spreadsheets and documents.
  • Competent in preparing presentations.