Job Description
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:
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 of 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!
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- You will represent Quality on multiple project teams intended to improve process, design or quality of products or procedures.
- You will collaborate intimately with cross-functional teams, oftentimes identifying qualification strategies, identifying and updating impacted documentation, and helping in any way you can to ensure projects advance appropriately.
- You will have a core understanding of our devices and help us investigate customer complaints and other quality issues and bring those learnings back to the project teams to further strengthen processes, designs, and quality.
- You will be a subject matter expert and be the go-to person
- You will establish, manage, and integrate risk management activities into other elements of the business and quality system.
- You will refine your understanding of quality processes and concepts, then help us further educate and train colleagues in creative and engaging ways.
- You will seek out the big picture – regularly interfacing between manufacturing, service, clinical, and commercial teams to solve problems and improve the company.
- You will review and audit process documentation and quality data (think SPC!) that you may or may not be responsible for.
- You will help us create, revitalize, and scale systems and processes.
- You will support internal and external audits.
- You will fill any identified gaps in our systems and processes!
Requirements
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:
- In-depth knowledge of quality engineering concepts, including design controls, production and process controls, and post-market surveillance
- Knowledge of ISO 11979, ISO 13485, ISO 14971, and 21 CFR 820/Part 11
- 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.
- 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
- Ability to train others who may have different backgrounds and learning styles to perform at a high level
- 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.
SUPERVISORY RESPONSIBILITIES:
- None
EDUCATION, EXPERIENCE, and TRAINING:
- Minimum of Bachelors’ Degree with at least seven years of experience in related field (if with a Master’s degree, then with at least five 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 15 days from the hiring date and on an annual basis.
CERTIFICATES, LICENSES, REGISTRATIONS:
- CQE or similar certification
COMPUTER SKILLS:
You will be working within spreadsheets, documents, and electronic systems. You will likely also be presenting to colleagues.