Quality Assurance Systems Analyst

1 week ago

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

RxSight Inc. is a pioneering company in the field of ophthalmic medical technology, based in Aliso Viejo, California. We have introduced the world's first and only adjustable intraocular lens (IOL) that is tailored post-cataract surgery. Our mission is to transform the premium cataract surgery experience by enabling surgeons to collaborate with their patients for optimal outcomes tailored to each individual eye.

Key Responsibilities

As a Quality System Specialist, your primary duties will include:

  • Gaining an in-depth understanding of our product offerings and devices while working closely with cross-functional teams to maintain seamless business operations.
  • Overseeing the management, monitoring, and enhancement of the non-conformance system to fulfill both internal and external standards.
  • Assisting in the upkeep of all quality management systems, including Corrective Actions, Document Control, and Employee Training.
  • Identifying innovative and effective methods to refine and optimize systems and processes as the organization expands.
  • Preparing and delivering quality metrics to educate stakeholders on the performance and health of our quality systems.
  • Supporting internal and external audit processes.
  • Ensuring adherence to Quality standards by tracking regulatory updates and managing external compliance requirements.
Qualifications

The ideal candidate will possess:

  • A solid understanding of quality systems and compliance within the medical device industry.
  • Familiarity with ISO 13485, 11979, 14971, and 21 CFR 820/Part 11.
  • Proficiency in Microsoft Word, Excel, Smartsheet, PowerBI, and other relevant software systems.
  • A detail-oriented mindset with a strong inclination towards problem-solving and a passion for continuous improvement.
  • Excellent teamwork and communication skills, with the ability to collaborate effectively across diverse teams.
  • The capability to train individuals with varying backgrounds and learning styles, demonstrating adaptability and flexibility in a dynamic environment.
Education and Experience

Requirements include:

  • A minimum of a Bachelor's Degree coupled with at least 2 years of relevant experience.
  • Proficiency in Microsoft Office applications.
  • Experience with QAD is a plus.
  • Must be a U.S. citizen or Permanent Resident.
  • Strong decision-making, organizational, and problem-solving skills, with a focus on teamwork.
  • Completion of required training as outlined in the training plan for this role.
  • Mandatory completion of specific training modules within designated timeframes.
Certifications

Preferred qualifications:

  • ASQ certification or CQE is recommended but not mandatory.
Technical Skills

Proficiency in:

  • Working with spreadsheets, documents, and electronic management systems.

  • Quality Assurance Systems Analyst

    1 week ago

    Aliso Viejo, California, United States RXSIGHT INC Full time

    Job OverviewRxSight Inc. is a pioneering company in ophthalmic medical technology, renowned for its innovative adjustable intraocular lens (IOL) designed for post-cataract surgery customization. Our mission is to transform the premium cataract surgery experience, empowering surgeons to collaborate with patients for optimal results tailored to each unique...

  • Quality Assurance Systems Coordinator

    1 week ago

    Aliso Viejo, California, United States RXSIGHT INC Full time

    Job OverviewRxSight Inc. is a pioneering company in ophthalmic medical technology, known for its innovative adjustable intraocular lens (IOL) that is tailored post-cataract surgery. Our mission is to transform the premium cataract surgery experience, enabling surgeons to collaborate with patients for optimal outcomes tailored to individual needs.Key...

  • Quality Assurance Specialist

    2 days ago

    Aliso Viejo, California, United States RxSight, Inc. Full time

    About RxSight, Inc.RxSight, Inc. is a leading ophthalmic medical technology corporation headquartered in California, dedicated to revolutionizing the premium cataract surgery experience.Job SummaryWe are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our Quality Systems & Compliance team. As a Quality Assurance...

  • Quality Assurance Specialist

    3 days ago

    Aliso Viejo, California, United States RXSIGHT INC Full time

    Job DescriptionRxSight 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.Job Summary:We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our Quality Systems & Compliance team. As a...

  • Quality Assurance Manager

    1 day ago

    Aliso Viejo, California, United States Spyglass Pharma Full time

    Job DescriptionAbout SpyGlass PharmaSpyGlass Pharma is a leading pharmaceutical company dedicated to developing innovative solutions for glaucoma and cataract surgery/intraocular lens replacement. Our mission is to improve patients' quality of life through cutting-edge technology and expertise.Our team comprises professionals with diverse expertise in...

  • Quality Assurance Lead

    2 days ago

    Aliso Viejo, California, United States Spyglass Pharma Full time

    Job DescriptionAbout SpyGlass PharmaSpyGlass Pharma is a leading pharmaceutical company dedicated to developing innovative solutions for glaucoma and cataract surgery/intraocular lens replacement. Our mission is to improve patients' quality of life through cutting-edge technology and expertise.Our team comprises professionals with diverse expertise in...

  • Quality Assurance Specialist

    5 days ago

    Aliso Viejo, California, United States Spyglass Pharma Full time

    Job DescriptionAbout SpyGlass PharmaSpyGlass Pharma is a leading pharmaceutical company dedicated to developing innovative solutions for glaucoma and cataract surgery/intraocular lens replacement. Our mission is to improve patients' quality of life through cutting-edge technology and expertise.Our team comprises professionals with diverse expertise in...

  • Quality Assurance Manager

    1 week ago

    Aliso Viejo, California, United States Spyglass Pharma Full time

    Job OverviewSalary Range: $135,000 - $150,000About SpyGlass Pharma:SpyGlass Pharma is dedicated to advancing innovative solutions for unmet needs in the fields of glaucoma and cataract surgery, as well as intraocular lens replacement. Our mission is to drive transformative changes in global eye care.Our team is composed of experts from various disciplines...

  • Staff Engineer, Quality Assurance

    3 days ago

    Aliso Viejo, California, United States MicroVention Full time

    Job SummaryWe are seeking a highly skilled Staff Engineer, Quality Assurance to join our team at MicroVention. This is a critical role that will lead design control activities for the development and manufacture of medical devices and resolve product quality issues.Key ResponsibilitiesProvide technical expertise in quality assurance, including design...

  • Senior Quality Assurance Engineer

    1 week ago

    Aliso Viejo, California, United States MicroVention-Terumo Full time

    About MicroVention-TerumoAs a prominent player in the medical device industry, MicroVention-Terumo is dedicated to excellence in quality assurance and product development.Position Overview:The Staff Quality Engineer (New Products) will play a pivotal role in liaising with Research & Development and Manufacturing teams to manage design control processes...

  • Senior Quality Assurance Engineer

    2 weeks ago

    Aliso Viejo, California, United States MicroVention-Terumo Full time

    About MicroVention-TerumoAs a leading entity in the medical device industry, MicroVention-Terumo is dedicated to innovation and excellence. We are currently seeking a Staff Engineer, Quality (New Products) to enhance our quality assurance processes in collaboration with R&D and Manufacturing teams.Key Responsibilities:Offer specialized knowledge in quality...

  • Senior Quality Assurance Engineer

    2 weeks ago

    Aliso Viejo, California, United States MicroVention Full time

    Job OverviewCollaborate with Research & Development and Manufacturing teams to spearhead design control initiatives for the creation and production of medical devices while addressing product quality challenges. Deliver quality assessments during design evaluations. Offer insights and direction for project design strategies, risk management, design...

  • Senior Quality Assurance Specialist, R&D

    5 days ago

    Aliso Viejo, California, United States MicroVention Full time

    Job SummaryWe are seeking a highly skilled Staff Engineer, Quality Assurance to join our team at MicroVention. As a key member of our R&D department, you will be responsible for leading design control activities and ensuring the quality of our medical devices.Key ResponsibilitiesDesign Control: Lead design control activities for the development and...

  • Software Quality Assurance Specialist

    1 day ago

    Aliso Viejo, California, United States AWM Full time

    Job SummaryAward-winning company AWM is seeking a skilled Software Quality Assurance Engineer to join our team. As a key member of our software development team, you will play a crucial role in ensuring the quality and reliability of our cutting-edge software solutions.About the RoleWe are looking for a highly motivated and detail-oriented individual to test...

  • Quality Assurance and Calibration Program Manager

    5 days ago

    Aliso Viejo, California, United States RXSIGHT INC Full time

    Job DescriptionRxSight 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...

  • Quality Assurance Compliance Specialist

    2 weeks ago

    Aliso Viejo, California, United States RXSIGHT INC Full time

    Job OverviewRxSight Inc. is a pioneering company in the field of ophthalmic medical technology, located in Aliso Viejo, California. We have introduced the world's first and only adjustable intraocular lens (IOL) tailored to individual patient needs post-cataract surgery. Our mission is to transform the premium cataract surgery experience, enabling surgeons...

  • Quality Assurance Specialist

    2 weeks ago

    Mission Viejo, California, United States ScriptPro Full time

    Job Summary ScriptPro seeks a dedicated Quality Assurance Specialist to contribute to our agile development process. This role focuses on ensuring the delivery of high-quality software solutions across our product line. You will play a vital part in evaluating, reproducing, and investigating issues related to software, hardware, reporting, and operating...

  • Quality Assurance Systems Lead

    1 week ago

    Mission Viejo, California, United States Wonderful Citrus Full time

    Job OverviewCompany Overview:Wonderful Citrus stands as the foremost integrated grower, shipper, and packer of fresh citrus in the United States, specializing in a variety of citrus fruits including clementines, mandarins, navel oranges, and more. With over 58,000 acres of citrus cultivation, we ensure a consistent supply of high-quality products shipped...

  • Sr. Benefit Analyst

    1 month ago

    Aliso Viejo, California, United States Marsh Full time

    Sr. Benefit AnalystDescription:Work directly with Client Service Team (Client Managers, Client Executives and Principals) to provide a high level of client support in response to routine client requests and needs, act as liaison with carriers, and maintain client and carrier information. Essential Duties & ResponsibilitiesSupport the Client Service Team with...

  • Senior QA Engineer

    1 week ago

    Aliso Viejo, California, United States Insight Global Full time

    Senior QA EngineerWe are seeking a highly skilled Senior QA Engineer to play a critical role in ensuring the quality and reliability of our software products.Key Responsibilities:Participate in daily collaboration with the team to ensure alignment on project goals and objectives.Handle Jira tickets with pending tasks assigned by the manager or leads, working...