Quality Control Inspector III chez Alphatec Spine

Description

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      

Education and/or Experience

• 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).

ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.

Salary Range

Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate’s qualifications, education, skill set, years of experience, and internal equity. $26- $30 an hour full-time salary range.

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k, IRA)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)
• Free Food & Snacks
• Wellness Resources
• Stock Option Plan