Senior Director, Quality Engineering

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. 

At RxSight, the Quality 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.

The Quality Engineering team is focused on:

• Making things happen
• Making problems go away, and
• Making improvements

The Quality Engineering team, like the rest of Quality, is a service-oriented organization that closely works and partners with the R&D Engineering and Operations teams.

The Senior Director of Quality Engineering is responsible for leading and mentoring the Quality Engineering team with responsibilities over all of the quality engineering functions, including process controls, good manufacturing practices, process validation support, test method validation support, equipment qualification, batch record review, and product release. The Senior Director of Quality Engineering supports the day-to-day operations and engineering

projects.

If you can see yourself as member of this, read on!

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• You will lead, guide, and mentor quality engineering personnel in support of the development and manufacture of all RxSight products.
• You and your team will establish, maintain and improve design and process controls.
• You and your team will support day-to-day operations and engineering projects.
• You and your team will support validation and equipment qualification activities, Design History File creation and maintenance, Engineering Change Requests, and the creation and update of associated risk management documentation.
• You and your team will provide oversight of the product lines both in development and in manufacturing for compliance to relevant standards and quality system regulations  including but not limited to FDA, ISO, IEC, ANSI, AAMI, CMDCAS, COFEPRIS, TGA, ANVISA, MHLW, KMFDS, etc. · You and your team will support in the management of internal and external audits. · You will fill any identified gaps in our systems and processes 

Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

• Knowledge of intraocular lenses, ophthalmic consoles, reusable medical devices, and disposable medical devices
• Knowledge of the manufacturing environment in the medical device industry
• Knowledge of ISO 13485 and 21 CFR 820/Part 11
• Knowledge of IEC 60601-1, ISO 14971, and ISO 11979
• Knowledge of quality system requirements in the US, EU, Mexico, Canada, Australia, Brazil, Japan, South Korea, and other markets
• Curious mindset with a strong sense of integrity, accountability, and commitment to service.
• Process-oriented with an ability to view potential pitfalls and issues from various perspectives.
• Highly passionate individual that notices and cares about the 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:

You will manage direct reports who are responsible for design and process controls. This may include:

• Managers
• Quality Engineers
• Scientists
• Quality Technicians/Associates/Specialists
• Subject Matter Experts

EDUCATION, EXPERIENCE, and TRAINING:

• Minimum of Bachelors’ Degree in a scientific or technical field with at least fifteen years of experience in related field (if with a Master’s degree, then with at least twelve years of experience in the field)
• Training to be completed per the training plan for this position as maintained in the document