Senior Director of Quality Engineering

7 days ago

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

**About Us**

RxSight Inc. is a leading ophthalmic medical technology corporation dedicated to revolutionizing the premium cataract surgery experience. Our mission is to partner with surgeons and patients to achieve optimized results for every unique eye.

**Our Quality Team**

We are a customer-focused organization, committed to making all of our customers happy. Our Quality team is focused on improving the people, the product, and the process. We are a service-oriented organization that closely works and partners with the R&D Engineering and Operations teams.

**Job Summary**

We are seeking a highly skilled and experienced Senior Director of Quality Engineering to lead and mentor our Quality Engineering team. The successful candidate will be responsible for leading all quality engineering functions, including process controls, good manufacturing practices, process validation support, test method validation support, equipment qualification, batch record review, and product release.

**Key Responsibilities**

  • Lead, guide, and mentor quality engineering personnel in support of the development and manufacture of all RxSight products.
  • Establish, maintain, and improve design and process controls.
  • Support day-to-day operations and engineering projects.
  • 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.
  • Provide oversight of the product lines both in development and in manufacturing for compliance to relevant standards and quality system regulations.
  • Support in the management of internal and external audits.

**Requirements**

  • Minimum of 15 years of experience in a related field, with a Bachelor's Degree in a scientific or technical field.
  • 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.
  • 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.
  • 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**

The Senior Director of Quality Engineering will manage direct reports who are responsible for design and process controls. This may include Managers, Quality Engineers, Scientists, Quality Technicians/Associates/Specialists, and Subject Matter Experts.

**Education, Experience, and Training**

  • Minimum of 15 years of experience in a related field, with a Bachelor's Degree in a scientific or technical field.
  • Training to be completed per the training plan for this position as maintained in the document control system.

**Certificates, Licenses, Registrations**

  • ASQ certification recommended but not required.

**Computer Skills**

The Senior Director of Quality Engineering will be working within spreadsheets, documents, and electronic systems. They will likely also be presenting to colleagues and executive management.

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