Senior Manager/Director/Senior Director, Quality Engineering

Job Description

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.

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.

The Senior Manager / Director / Senior Director, Quality Engineering ensures that product meet defined standards and specifications both in design and finished quality to RxSight’s customers and that quality system processes are established and monitored.

The Senior Manager / Director / Senior Director will oversee a department that is responsible for standards, quality improvements by constant vigilance of production systems ranging from quality system processes, LAL Production, LDD production, Accessories and new product release.

The position will identify defect trends and coordinate with Engineering, Production and Global Supply Chain to reduce identified defects both in Manufacturing and customer complaint data to ensure this goal is met.

They will report on yields as well as anticipate future quality issues by assessing design characteristics as embedded partners of the RD&E teams.

The Senior Manager of Quality Engineering is accountable for leading and mentoring the Quality Engineering team with responsibilities over the quality functions, including process controls, good manufacturing practices, risk management, process validation support, test method validation support, equipment qualification, batch record review, and product release.

The Senior Manager of Quality Engineering is a key member on current and future engineering projects.

Requirements :

ESSENTIAL DUTIES AND RESPONSIBILITIES :

• Lead, guide, and mentor quality engineering personnel in support of the establishment and improvement of quality system processes as well as the development and manufacture of all RxSight products.
• Continuously collaborate with cross-functional project teams and RxSight management, and participates in strategic project discussions involving resource allocations, resource balancing, and strategy
• Collaborate with process owners to establish dashboards and metrics to monitor quality system processes and continuously drive improvements to those processes
• Drive the establishment and transfer of routine testing activities from R&D to the appropriate team(s).
• Manage the supplier management program and supplier change requests, including risk assessments, project planning, and dissemination of information to cross-functional teams
• Investigate and determine the root cause of issues triggered by product monitoring testing, feasibility testing discoveries, V&V issues, and / or field complaints
• Perform product monitoring, including routine analysis of product performance data, SPC dashboard maintenance, root cause investigation, and routine dissemination of data to cross-functional teams
• Write and oversee the writing of technical documentation including, but not limited to, engineering reports, quality system procedures and work instructions, product development requirements, validation protocols, and reports
• Review and conduct change assessments for changes to parts, manufacturing processes, and labeling including describing change description, reason for change, and risk assessment for the change
• Manage corrective and preventive action projects
• Create, review, and update risk management documentation for all RxSight products and processes

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES :

• Knowledge of reusable medical devices and disposable medical devices. Knowledge of intraocular lenses and ophthalmic consoles is a plus.
• Knowledge of the manufacturing environment in the medical device industry
• Knowledge of
• ISO 13485 and 21 CFR 820 / Part 11
• IEC 60601-1
• ISO 14971
• ISO 11979
• ISO 10993
• ISO 11135
• Knowledge of quality system requirements in the US, EU, UK, Mexico, Canada, Australia, Brazil, Japan, South Korea, and other markets
• Ability to train others who may have different backgrounds and learning styles to perform at a high level
• Curious mindset with a strong sense of integrity, accountability, and commitment to service
• Excellent interpersonal, computer, communication, and presentation skills
• 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 seven to fifteen 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.

CERTIFICATES, LAND ICENSES, REGISTRATIONS :

ASQ certification recommended but not required

COMPUTER SKILLS :

You will be working within spreadsheets, documents, and electronic systems. You will likely also be presenting to colleagues and executive management.