Quality Engineer
Company: RxSight, Inc.
Location: Aliso Viejo
Posted on: May 8, 2022
|
|
Job Description:
RxSight has commercialized the world---s first and only
adjustable intraocular lens (IOL) that is customized after cataract
surgery. This intraocular lens can be adjusted non-invasively while
in the eye, allowing the post-cataract surgery patient to see
clearly at distance without the use of eyeglasses or contact
lenses. The application of light to the implanted Light Adjustable
Lens (LAL---) will fine-tune the patient---s lens power to their
specific visual need.This technology sets the stage for a series of
lens products from RxSight that will have widespread application in
cataract and refractive surgery as well as outside the field of
medicine. OVERVIEW: The Quality Engineer position requires
significant learning agility and adaptability in order to
successfully operate in a highly dynamic and innovative
environment. The Quality Engineer is responsible for managing the
complaint handling process, including all intake, reportability
determination, risk assessment, and investigation activities. In
addition, the Quality Engineer will set up and manage the Good
Manufacturing Practices for the production of RxSight devices and
accessories; support the development of RxSight devices and
accessories; and develop, implement and maintain policies and
procedures to ensure compliance with Quality System Regulations
(QSR---s) for medical devices. The Quality Engineer will be
responsible for establishing documentation control and approval
workflows to support manufacturing and testing for processes, test
methods, test results, batch records, etc. for manufacturing and
work with Product Development, Manufacturing, and Quality Control
departments to ensure product quality and regulatory compliance.
ESSENTIAL DUTIES AND RESPONSIBILITIES: -- Manage the intake and
follow-up of complaints and other forms of customer feedback --
Investigate or facilitate the investigation of complaints --
Maintain complaint documentation, including reportability
decisions, complaint investigations, and all applicable supporting
documentation -- Manage the decontamination and disposition of
returned materials -- Performs and documents reportability
decisions in accordance with applicable regulations -- Monitor
complaint data for trends -- Lead the review of all material review
board dispositions within functional area -- Read, comprehend and
follow documents outlining all procedures related to the light
adjustable lens -- Establish and maintain document control
practices for the manufacturing area including batch records, data
systems, and material release -- Create, review, and maintain risk
management files within functional area -- Review test results and
release material for use -- Establish and maintain material control
practices for the production area -- Perform audits of
manufacturing practices to confirm operations to established
processes -- Maintain and update equipment development, validation,
and installation process -- Control materials for use in
manufacturing and non-conforming materials -- Work with suppliers
to ensure quality system requirements are understood and
successfully met -- Maintain compliance to latest standards for
optics, electronics, mechanics, and software as required --
Maintain working knowledge of all U.S. and International standards
relating to medical devices including biocompatibility,
physico-chemical, optical mechanical, IEC/EMC, ISO, etc. for
company as required -- Perform corrective actions and root cause
analysis as required -- Initiate change requests and approve change
requests -- Support audits as necessary with information from the
manufacturing and development areas -- Ensure compliance to
company---s product development standards for new product
development REQUIRED KNOWLEDGE, SKILLS AND ABILITIES: --
Knowledgeable of 21 CFR 820, 21 CFR 807, 21 CFR 806, and 21 CFR
Part 11 -- Knowledgeable of ISO 13485 and 14971 -- Knowledgeable of
IEC 60601-1 -- Knowledgeable of requirements for medical devices in
US, EU, Mexico, Canada, Australia, Brazil, Japan, and other markets
-- Able to perform product failure analysis -- Able to perform
basic statistical analysis -- Strong interpersonal skills,
well-established computer, communication and presentation skills --
Able to manage complaints, CAPA, training, non-conformances, change
control, engineering change requests, and other quality systems
Ability to travel up to 25 percent EDUCATION, EXPERIENCE, and
TRAINING: -- BS degree in an engineering or science discipline or
combined education and experience. -Minimum of 2 years of
experience performing quality assurance/regulatory affairs and
developing processes in a manufacturing and/or product development
environment preferably in the medical device industry.
CERTIFICATES, LICENSES, REGISTRATIONS: -- ASQ certification (CQE,
CSQP) recommended but not required -- RAC certification recommended
but not required
Keywords: RxSight, Inc., Aliso Viejo , Quality Engineer, Engineering , Aliso Viejo, California
Click
here to apply!
|