Senior Quality Systems Engineer III

Description

The Senior Quality Systems Engineer III is responsible supporting the implementation, management, and improvement of RxSight’s Quality System, including but not limited to, document control, training, change management, corrective and preventive actions, nonconforming materials, and complaints. The Senior Quality Systems Engineer III will also serve as a mentor and role model for other quality personnel and will be a key member in internal and external audits.

Requirements

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Manage individual corrective and preventive action projects as well as the overall system and regularly extract and provide data for management review, post-market surveillance, and other activities, as required
• Guide and mentor quality personnel in support of the establishment and improvement of quality system processes
• Collaborate with other quality personnel to establish dashboards and metrics to monitor quality system processes and continuously drive improvements to those processes
• Investigate and determine the root cause of issues triggered by product monitoring testing and/or field complaints
• 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 quality system processes including describing change description, reason for change, and risk assessment for the change
• Support internal, external, and supplier audits

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 quality system requirements in a medical device manufacturing environment
• Knowledge of 
• ISO 13485 and 21 CFR 820/Part 11
• ISO 14971
• 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:

None

EDUCATION, EXPERIENCE, and TRAINING:

• Minimum of Bachelor’s Degree in a scientific or technical field with at least seven years of experience in a 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.
• 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 30 days from the hiring date and on an annual basis.

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.