Quality Technician I - LAL jobs in United States
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RxSight, Inc. · 3 days ago

Quality Technician I - LAL

RxSight, Inc. is an ophthalmic medical technology corporation that has commercialized the world’s first adjustable intraocular lens. The Quality Technician I will perform quality functions to support various quality standards and regulations, including FDA and CGMP, and will be responsible for auditing production records, inspecting process outputs, and ensuring compliance with quality systems.

BiotechnologyEyewearHealth CareMedical Device
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H1B Sponsor Likelynote

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

Qualification

Quality AssuranceCleanroom EnvironmentMedical Device ManufacturingMicrosoft ExcelMicrosoft WordIntellectual CuriosityProfessionalismCommunicationAttention to Detail

Required

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
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

Preferred

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

Company

RxSight, Inc.

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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.

H1B Sponsorship

RxSight, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)

Funding

Current Stage
Public Company
Total Funding
$350.98M
Key Investors
Oxford Finance LLCBiomedical Advanced Research and Development Authority (BARDA)Visionary Venture Fund
2024-05-08Post Ipo Equity· $115M
2023-02-07Post Ipo Equity· $50M
2021-07-29IPO

Leadership Team

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Ron Kurtz
Co-President and CEO
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Robert Grubbs
Co-Founder
Company data provided by crunchbase