Advita Ortho

Orthopedic implants and AI-enabled surgical technologies

QC Technician

Inspection & TestUpdated on Nov 13

Full-timeGainesville, FL, USANo salary listedIn-person

About the Job

Requirements

A high school diploma or GED is required.
Attention to detail, accuracy, and documentation skills are required.
Aptitude to learn basic quality measurement equipment and tools, including profile overlays, calipers, and hand gages, is required.
Basic computer skills are required.
Familiarity with 21 CFR Part 820 and ISO 13485 subclauses on acceptance criteria is required.
Entry-level understanding of GD&T ASME Y14.5 is required.
Ability to use micrometers, calipers, depth gauges, height gauges, a visual comparator, and a vision system is required.

Responsibilities

Ensure all products meet product specifications before final acceptance, including review and completion of applicable documentation in compliance with FDA and ISO standards as delineated by the Quality Management System.
Perform and document inspection requirements following approved SOPs and WIs for incoming and finished products, including implants, instrumentation, raw material, and trays.
Document and notify the QC Supervisor or Manager of non-conformances.
Create non-conformance records, segregate non-conforming product, and complete assigned tasks in the non-conformance system.
Assist with the Material Review Board process and execute non-conformance dispositions.
Perform product inspection according to established sampling plans.
Maintain ERP system status and product location to ensure accurate identification and traceability.
Perform stock audits as assigned by the QC Supervisor or Manager.
Perform environmental monitoring tasks as needed.
Perform First Article Inspection and/or Special Inspections according to established procedures.
Know and apply the Quality System and appropriate federal and international standards.
Assist and support other employees, teams, and sales personnel as necessary.

Desired Qualifications

Prior work in a Quality department in a regulated industry is preferred.
Experience utilizing Geometric Dimensioning and Tolerancing (GD&T) is preferred.

To ensure all products meet product specifications prior to final acceptance. This includes review and completion of applicable documentation. Additionally, these tasks shall be accomplished in compliance with FDA and ISO Standards as delineated by the Quality Management System.

Perform and document inspection requirements following approved SOPs and WIs for incoming and finished products including implants, instrumentation, raw material, and trays.
- Document and notify QC Supervisor / Manager of non-conformances (NC).
Create NC record, segregate NC product, and completion of NC system tasks as assigned by QC Supervisor/Manager.
Assist with Material Review Board process and execute NC dispositions.
Perform product inspection in accordance to established Sampling Plans.
Maintain ERP system status and location of product to ensure accurate identification and traceability.
Perform Stock Audits as assigned by QC Supervisor / Manager.
As needed - Perform Environmental Monitoring tasks.
Perform First Article Inspection (FAI) and/or Special Inspections (SI) per established procedures.
Know and apply the Quality System and any appropriate Federal and International standards.
Assist and support other employees, teams, and sales personnel as necessary.

Education:

High School Diploma or GED required

Experience:

Prior work in a Quality department in a regulated industry preferred.
Experience utilizing Geometric Dimensioning and Tolerancing (GD&T) preferred.

Functional/Technical Knowledge, Skills and Abilities Required:

Attention to detail, accuracy, and documentation skills.
Aptitude to learn the use of basic Quality measurement equipment and tools such as profile overlays, calipers, hand gages, etc.
Basic computer skills
Familiar with 21 CFR Part 820 and ISO-13485 subclauses on Acceptance Criteria.
Entry level understanding of GD&T ASME Y14.5.
Ability to use Micrometers, Calipers, Depth-gauge, Height gauge, Visual Comparator, and Vision-System.

About the Company

Advita Ortho

Orthopedic implants and AI-enabled surgical technologies

Advita Ortho designs and sells orthopedic implants and integrated surgical technologies, including established lines like Equinoxe Shoulder, Vantage Ankle, Alteon Hip, and Truliant Knee. Its products pair implants with tools such as Newton balancing technology and GPS navigation to guide surgeries, while using data, AI, and machine learning to build a surgical ecosystem that supports in-OR decision-making. The company differentiates itself by combining hardware with data-driven software to improve efficiency and outcomes, backed by experienced leadership and significant financial support from its investors. Its goal is to deliver high-quality implants and connected surgical technology that enhance patient outcomes and streamline operating-room workflow globally.

Company size: 201-500
Company stage: Debt Financing
Total funding: $35M
Headquarters: Gainesville, FL
Founded: 2025

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