Senior Manager/Director/Senior Director, Quality Engineering

3 weeks ago

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

RxSight Inc. is a leading ophthalmic medical technology corporation headquartered in California, dedicated to revolutionizing the premium cataract surgery experience. The company's mission is to partner with surgeons and patients to achieve optimized results for every unique eye.

The Senior Manager/Director/Senior Director, Quality Engineering is responsible for leading the Quality Engineering efforts within RxSight, reporting to the Vice President, Quality Assurance. This role ensures that products meet defined standards and specifications, both in design and finished quality, to meet RxSight's customers' expectations.

The Senior Manager/Director/Senior Director will oversee a department responsible for standards, quality improvements, and process controls. This includes identifying defect trends and coordinating with Engineering, Production, and Global Supply Chain to reduce identified defects in Manufacturing and customer complaint data.

The Senior Manager of Quality Engineering is accountable for leading and mentoring the Quality Engineering team, with responsibilities over quality functions, including process controls, good manufacturing practices, risk management, and product release. This role is a key member on current and future engineering projects.

Key Responsibilities
  • Lead, guide, and mentor quality engineering personnel in support of quality system processes and product development.
  • Collaborate with cross-functional project teams and RxSight management to drive quality improvements and process controls.
  • Establish dashboards and metrics to monitor quality system processes and drive continuous improvements.
  • Manage the supplier management program and supplier change requests, including risk assessments and project planning.
  • Investigate and determine the root cause of issues triggered by product monitoring testing, feasibility testing discoveries, and field complaints.
  • Perform product monitoring, including routine analysis of product performance data and root cause investigation.
  • Write and oversee the writing of technical documentation, including engineering reports, quality system procedures, and product development requirements.
  • Review and conduct change assessments for changes to parts, manufacturing processes, and labeling.
  • Manage corrective and preventive action projects.
  • Create, review, and update risk management documentation for all RxSight products and processes.
Requirements
  • Knowledge of reusable medical devices and disposable medical devices, with a focus on intraocular lenses and ophthalmic consoles.
  • Knowledge of the manufacturing environment in the medical device industry, including ISO 13485 and 21 CFR 820/Part 11.
  • Ability to train others and lead cross-functional teams.
  • Curious mindset with a strong sense of integrity, accountability, and commitment to service.
  • Excellent interpersonal, computer, communication, and presentation skills.
Supervisory Responsibilities

The Senior Manager/Director/Senior Director will manage direct reports responsible for design and process controls, including Managers, Quality Engineers, Scientists, Quality Technicians/Associates/Specialists, and Subject Matter Experts.

Education, Experience, and Training
  • Minimum of a Bachelor's Degree in a scientific or technical field, with seven to fifteen years of experience in a related 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 Manager/Director/Senior Director will work within spreadsheets, documents, and electronic systems, presenting to colleagues and executive management.

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