Under Quality supervision, evaluates materials and products to ensure conformance to drawing requirements, procurement specifications and approved procedures. Evaluations include dimensional, functional, cosmetic and documentation as required per applicable inspection plan.
Perform Quality Control inspections, as required per ATEC procedures
Read, understand, and interpret engineering (blueprint) drawings and associated GD&T (Geometric Dimension & Tolerances)
Perform mechanical, visual and functional inspection. Utilization of Micro-Vu or similar lighting inspection systems preferred
Engage with respective department members to maintain best inspection practices, foster a cooperative work environment, propose improvements when inefficiencies are observed
Generate, complete, and maintain quality documentation such as inspection records, non-conformance reports, deviation, and scrap forms
Process non-conforming materials following established procedures, able to identify and segregate non-conforming materials, transact as required in the company ERP (SAP)
Perform transactions in 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
Other duties as assigned
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.
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, 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
Education and Experience High School Diploma or equivalent and 2-5 years of experience; experience working in a medical device industry experience 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.
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