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Quality Assurance Specialist

2 months ago


Carlsbad, United States Alphatec Spine Full time
Job Summary

We are seeking a highly skilled Quality Control Inspector II to join our team at Alphatec Spine, Inc. This role is responsible for evaluating materials and products to ensure conformance to drawing requirements, procurement specifications, and approved procedures.

Key Responsibilities
  • Perform quality control inspections, as required per ATEC procedures
  • Read, understand, and interpret engineering drawings and associated GD&T (Geometric Dimension & Tolerances)
  • Perform mechanical, visual, and functional inspections
  • Generate, complete, and maintain quality documentation, such as inspection records, non-conformance reports, deviation, and scrap forms
  • Process non-conforming materials following established procedures
  • Perform transactions in the ERP system, as necessary to release product from Inspection
  • Read and conform to all company policies and procedures
  • Perform documentation evaluations
  • Interface with other departments, including Purchasing, Shipping, Receiving, Manufacturing, and Engineering, as well as Supplier representatives
  • Assist auditors during internal audits
Requirements
  • Good communication skills, both verbal and written
  • Strong organization skills and attention to detail
  • Basic math and computer skills required
  • Firm understanding of 21 CFR (Code of Federal Regulations), Part 820
  • 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
Education and Experience

High School Diploma or equivalent and 1-2 years experience; experience working in a medical device industry experience preferred.

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).

Alphatec Spine, Inc. is an equal opportunity employer and complies with all applicable federal, state, or local laws. We will make reasonable accommodations that are necessary to comply with disability discrimination laws.

Salary Range: $23 to $27 Full-Time Hourly Salary.