Quality Technician - LAL

RxSight® is an ophthalmic medical technology corporation headquartered in Aliso Viejo, CA that has commercialized the world’s first and only adjustable intraocular lens (IOL) customized after cataract surgery. The mission is to revolutionize the premium cataract surgery experience by enabling surgeons to partner with patients to achieve optimized results for every unique eye.

Quality Assurance Technician supporting FDA, CGMP, and ISO 13485 compliance. Responsible for quality functions across LAL production, QA/QC, manufacturing transfer, and facility support.

• 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.
• Perform 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 support 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.
• Perform laboratory notebook audits, inventory audits, and maintain 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.

• Prior experience working in a 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 with in a medical device company or regulated industry preferred.
• Proficiency with Microsoft Word, Microsoft Excel.

Huntington Beach, CA

$25.00 to $27.00 per hour