Senior Quality Technician jobs in United States
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C. Light Technologies, Inc. · 4 hours ago

Senior Quality Technician

C. Light Technologies is a healthtech startup focused on creating AI-enabled digital tools for eye and brain health. The Senior Quality Technician will support quality operations within the ISO 13485 certified Quality Management System, ensuring compliance with FDA regulations and collaborating with various teams to maintain high-quality standards.

Health CareMedicalMedical DeviceSoftware

Responsibilities

Manage customer feedback and customer complaints (CF) by capturing user input, documenting complaint content, and initiating investigations in the company’s eQMS system
Support root cause analysis, verification activities, and documentation of corrective actions under guidance from senior quality staff or external quality consultants
Maintain document control across the eQMS, ensuring SOPs, work instructions, forms, inspection records, service forms, and installation records are current, properly versioned, and approved
Support CAPA and Nonconformance (NCR) processes by collecting data, documenting evidence, and coordinating required records with quality consultants
Perform incoming inspection of parts and materials, including reviewing drawings, identifying CTQ characteristics. Flagging nonconforming items, quarantine NC parts and intiate NCMR
Execute final product quality inspections, including review of DHR and LHR completeness, software and firmware version checks, and hardware performance testing
Assist with employee training execution, SOP training, assembly instruction training, and maintenance of training records
Maintain audit readiness by organizing quality records, purchase orders, inspection reports, training files, and internal audit documentation
Support internal audits, supplier audits, and SCAR documentation in collaboration with external quality consultants
Take charge of equipment calibration. Sending out to qualified calibration house and maintaining the schedule. Checking calibration requirements are in place
Look after Preventive Maintenance, check logs and forms are up to date and properly documented

Qualification

ISO 13485FDA 21 CFR 820EQMS systemRoot cause analysisCAPA processesCommunicatorDetail-orientedTeam collaboration

Required

Detail-oriented, hands-on quality professional comfortable working in a fast-paced startup environment
Able to follow structured quality processes while adapting to evolving operational needs
Comfortable working under delivery pressure and meeting deadlines
Strong communicator with cross-functional teams including engineering, manufacturing, and regulatory talent experience in quality management roles

Benefits

Premium Medical, Dental and Vision Plan
Free cool developer swag
Lunch perks
Paid vacations and holidays
Simple IRA plan for retirement
Nice startup working environment and culture

Company

C. Light Technologies, Inc.

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C. Light is a healthtech company that creates objective digital tools and solutions with the aim to identify neuro-ocular signatures.

Funding

Current Stage
Early Stage
Total Funding
$5.19M
Key Investors
Alzheimer's Drug Discovery FoundationCreative Ventures
2021-08-04Series Unknown· $0.25M
2021-02-02Seed· $4.1M
2020-02-04Pre Seed· $0.1M

Leadership Team

C
Christy Sheehy
CEO & Co-Founder
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Company data provided by crunchbase