QC Technician

Advita Ortho, LLC; Gainesville (FL); Sur place; USD 42 000 - 54 000; Plein temps

Résumé du poste

Advita Ortho, LLC is seeking a QC Technician in Gainesville, FL to ensure product conformance to specifications. You will perform and document inspections of incoming materials, implants, instrumentation, and finished goods, ensuring traceability and regulatory compliance under FDA/ISO standards.

Responsibilities include documenting non-conformances, creating NC records, assisting with MRB dispositions, and maintaining ERP accuracy.

Qualifications

• High School Diploma or GED required.
• Experience in a regulated industry preferred.
• 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 basic quality measurement equipment.

Responsabilités

• Perform and document inspections for incoming and finished products per SOPs and WIs.
• Document and notify QC Supervisor/Manager of non-conformances (NC).
• Create NC records, segregate NC products, and complete NC system tasks.
• Assist with Material Review Board processes and NC dispositions.
• Perform product inspections per established Sampling Plans.
• Maintain ERP status and traceability of products.
• 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).
• Apply the Quality System and applicable Federal/International standards.
• Assist and support other employees, teams, and sales personnel as necessary.

Connaissances

Attention to detail

Documentation skills

GD&T knowledge

Basic computer skills

Regulatory awareness

Measurement basics

Formation

High School Diploma or GED

Outils

Micrometers

Calipers

Depth gauge

Height gauge

Vision system

Visual comparator

Description du poste

QC Technician

Department: Quality

Employment Type: Full Time

Location: Gainesville, FL

Reporting To: Quality Control Manager

Description

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.

Key Responsibilities

• 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.

Skills, Knowledge and Experience

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.