What are the responsibilities and job description for the Quality Inspector II position at Alphatec Spine?
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.
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k, IRA)
- Life Insurance (Basic, Voluntary & AD&D)
- Paid Time Off (Vacation, Sick & Public Holidays)
- Short Term & Long Term Disability
- Free Food & Snacks
- Stock Option Plan