Quality Technician I - LAL

RxSight, Inc.•Aliso Viejo, CA

21d

About The Position

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. OVERVIEW: Performs quality functions to support IS013485, FDA, CGMP, Quality System Regulations, management reporting, LAL production/QA/QC, chemistry QA/QC, product release, in-process inspection, incoming inspection, quality process improvements for LDD, manufacturing transfer, and facility support.

Requirements

Prior experience of working in cleanroom environment and/ or medical device manufacturing is highly preferred.
Professional, responsible, energetic, and accountable.
Excellent communication skills.
Intellectually curious and eager to learn.
Individual must be Quality oriented and possess a natural ability to pay attention to details.
Associate degree (A.A.) or equivalent from a two-year college or technical school; six months to one-year related experience and/or training; or equivalent combination of education and experience.
Experience within a medical device company or regulated industry preferred.
Microsoft Word; Microsoft Excel
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
Microsoft Word; Microsoft Excel; Microsoft Access; QuickBooks.

Nice To Haves

Prior experience of working in cleanroom environment and/ or medical device manufacturing is highly preferred.
Experience within a medical device company or regulated industry preferred.

Responsibilities

Read, comprehend, and follow documents related to manufacturing, inspection and quality systems for audits, compliance, and implementation.
Audit and approve production records.
Verify production process via auditing/observation and testing.
Inspect process output and product parameters against specifications.
Ensure routine compliance with process steps and proper documentation of records.
Maintain raw material lot information, monitor expiration date, and quarantine inventory when materials are expired.
Performs incoming inspection on raw materials and incoming sub-assemblies/finished goods.
Collect data for process, quality system, manufacturing quality and performance metrics and generate reports for management review.
Identify non-conformances, deviations, non-compliance, lack of calibration etc. and propose corrective actions to management.
Facilitate Manufacturing Review Board and supports non-conformance decision process.
Govern and transact materials physically and through electronic system.
Monitors laboratory and engineering equipment to ensure compliance with preventive maintenance and calibration programs.
Performs laboratory notebook audits, inventory audits, and maintains QA retains.
Take initiatives for the process improvements changes as related to manufactured components and finished products for LAL.
Responsible for assisting the Quality Assurance team with any ad hoc reports and assignments as required.
Perform incoming inspection and lot control activities of materials and parts.
Assist Quality, Manufacturing and R&D groups in running validation, verification, and developmental studies, and defining processes.
Development of inspection techniques and transfer to production and everyday use.
Monitor gowning and cleanroom logbook check per SOP to ensure all section of the cleaning log has been filled accurately and completely.
Provide Good Manufacturing Practices (GMP) and Quality Standard Operating Procedures (SOP) training to relevant department.
Create and review First Article Inspection Reports when necessary.