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:

At RxSight, the Quality Engineering team fills the gaps wherever they exist, lending a hand whenever it’s needed, and even sometimes when it’s not. We are focused on improving the people, the product, and the process. While it’s not in the name, we are very much a customer-focused organization, dedicating our time and effort to making all our customers happy. Life is fast paced, but it doesn’t mean it can’t be fun as well. If you can see yourself as a member of this team, read on!

WHAT WE WILL ENTRUST TO YOU:

You will develop software documentation for product or non-product software verification and validation activities.
You will collaborate intimately with cross-functional teams on process improvements and changes for product software.
You will establish, administer and maintain risk management activities, including for vulnerability and cybersecurity monitoring.
You will investigate complex product and non-product software quality and compliance issues, analyze results, develop reports, make recommendations, and implement improvements to address those issues.
You will review and audit documentation and processes that you may or may not be responsible for.
You will have a core understanding of the Light Delivery Device and be comfortable joining V&V efforts as they arise
You will seek out the big picture – regularly interfacing between manufacturing, service, clinical, and commercial teams.
You will support internal and external audits, especially when the topic is software!

YOUR KNOWLEDGE, SKILLS, and EXPERTISE:

In-depth knowledge of Cybersecurity (and willingness/interest in staying on top of the ever-changing landscape)
Substantial knowledge of principles, theories, and concepts relevant to the software development lifecycle
Knowledge of IEC 62304, ISO 13485, ISO 14971, and 21 CFR Part 11
Knowledge of requirements for software in medical devices and software as a medical device 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.
Highly passionate individual that notices and cares about design details and customers’ (internal and external) experiences with ability to link details to overall business strategy and direction.
Excellent interpersonal, computer, communication, and presentation skills
Self-starter with ability to take a leadership role in an unstructured environment.
Excellent teamwork skills with proven ability to collaborate across multiple disciplines and ability to influence cross-functional teams without formal authority.

WHO YOU WILL MANAGE:

You get the opportunity to focus on yourself!

YOUR EDUCATION, EXPERIENCE, AND TRAINING:

Minimum of Bachelors’ Degree with at least five years of experience in related field (if with a Master’s degree, then with at least four years of experience in the field).
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

YOUR CERTIFICATES, LICENSES, REGISTRATIONS:

CISSP or similar certification

COMPUTER SKILLS:

Coming from a software quality background, you already have plenty!

RxSight, Inc.

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