Quality Technician I

Job Description

Job Description

Description:

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:

Schedule: Monday-Friday 2pm-10:30pm

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

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Perform optical and mechanical inspections with optical comparator, LPS, OCT, Nanovea, interferometer, Spectro radiometer, radiometer, calipers, micrometers, visual inspection systems, microscope, Keyence, Confocal microscope, Smartscope, etc.
• Read, comprehend, and follow documents related to manufacturing, inspection and quality systems for audits, compliance, and implementation.
• Perform batch records review, in-process verification, and quality checks for LDD as required.
• 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.
• Revises, writes, and formats Quality System controlled documentation, including procedures, forms and engineering documents for LAL, incoming inspection, LDD, and chemistry.
• Initiates, implements and controls Change Notifications and Engineering Change Orders for LAL, incoming inspection and chemistry as required.
• 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 finishedproducts for LDD, 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.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Prior experience/ knowledge in optical and mechanical inspection techniques
• Experience in inspecting minute parts under microscope.
• Basic understanding of inspection processes
• 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.

SUPERVISORY RESPONSIBILITIES:

• This job has no supervisory responsibilities. This position may be responsible for leading cross training efforts to other inspectors, technicians.

EDUCATION, EXPERIENCE, and TRAINING:

• 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.

CERTIFICATES, LICENSES, REGISTRATIONS

• There are no specific requirements for this position.

COMPUTER SKILLS:

• Microsoft Word; Microsoft Excel; Microsoft Access; QuickBooks.

Notice to Staffing Agencies and Search Firms:

RxSight does not accept unsolicited resumes or candidate submissions from staffing agencies or search firms for any employment opportunities. All agency engagements must be authorized in writing for a specific position by RxSight’s Talent Acquisition department. Any resumes or candidate information submitted without such specific engagement will be considered unsolicited and the property of RxSight. No fees will be paid in the event a candidate is hired under these circumstances.