Quality Control Inspector III

Alphatec Spine•Memphis, TN

11d•$26 - $30

About The Position

Under Quality supervision, independently evaluates materials, components, subassemblies, and finished medical devices to ensure conformance to engineering drawings, specifications, and approved procedures. The Quality Control Inspector III serves as a technical subject-matter expert for inspection methods, drawing interpretation, GD&T, and quality system requirements. This role supports advanced inspections, nonconformance disposition activities, and provides technical guidance to lower-level inspectors. ESSENTIAL DUTIES AND RESPONSIBILITIES Perform advanced Quality Control inspections per ATEC procedures with minimal oversight Independently interpret and apply complex engineering drawings, specifications, and GD&T (Geometric Dimensioning & Tolerancing) Execute dimensional, visual, functional, and cosmetic inspections using advanced metrology equipment (Micro-Vu, vision systems, optical comparators, height gages, hand tools, etc.) Perform and review First Article Inspections (FAI), in-process inspections, and final release inspections Provide technical support and mentoring to QC Inspector I and II personnel regarding inspection techniques, acceptance criteria, and documentation requirements Identify and document nonconforming material in accordance with established procedures; support Nonconformance Record (NCR) activities as required Generate, review, and approve quality records including inspection records, nonconformance reports, deviations, scrap documentation, and rework verifications Ensure inspection records meet Good Documentation Practices (GDP), traceability, and audit readiness requirements Perform ERP (SAP) transactions required for inspection, material status changes, and product release Interface with Manufacturing, Engineering, Purchasing, Shipping/Receiving, and Supplier Quality to resolve inspection and quality issues Support root cause investigations, corrective actions, and continuous improvement initiatives related to inspection processes and product quality Assist and support internal, external, and regulatory audits as a technical inspection representative Identify opportunities to improve inspection efficiency, risk-based inspection strategies, and measurement system effectiveness Read, understand, and comply with all company policies, procedures, and quality system requirements Other duties as assigned

Requirements

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Strong communication skills, both verbal and written
Strong organization skills and attention to detail
Intermediate math and computer skills required
Firm understanding of 21 CFR (Code of Federal Regulations), Part 820, ISO 13485, Good Documentation Practices (GDP)
Firm understanding of ASTM (Association of Systems & Test Methods) standards and Heat Treat conditions per ASTM standards
Experience in a controlled or regulated environment required
Inspection experience with Optical Comparators, Vision Systems, hand tools, and other calibrated gauges
High School Diploma or equivalent
4-12 years of experience working in a manufacturing or medical device industry preferred.
Familiarity with quality concepts such as visual inspection and defect identification.
For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).

Responsibilities

Perform advanced Quality Control inspections per ATEC procedures with minimal oversight
Independently interpret and apply complex engineering drawings, specifications, and GD&T (Geometric Dimensioning & Tolerancing)
Execute dimensional, visual, functional, and cosmetic inspections using advanced metrology equipment (Micro-Vu, vision systems, optical comparators, height gages, hand tools, etc.)
Perform and review First Article Inspections (FAI), in-process inspections, and final release inspections
Provide technical support and mentoring to QC Inspector I and II personnel regarding inspection techniques, acceptance criteria, and documentation requirements
Identify and document nonconforming material in accordance with established procedures; support Nonconformance Record (NCR) activities as required
Generate, review, and approve quality records including inspection records, nonconformance reports, deviations, scrap documentation, and rework verifications
Ensure inspection records meet Good Documentation Practices (GDP), traceability, and audit readiness requirements
Perform ERP (SAP) transactions required for inspection, material status changes, and product release
Interface with Manufacturing, Engineering, Purchasing, Shipping/Receiving, and Supplier Quality to resolve inspection and quality issues
Support root cause investigations, corrective actions, and continuous improvement initiatives related to inspection processes and product quality
Assist and support internal, external, and regulatory audits as a technical inspection representative
Identify opportunities to improve inspection efficiency, risk-based inspection strategies, and measurement system effectiveness
Read, understand, and comply with all company policies, procedures, and quality system requirements
Other duties as assigned