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Senior Quality Engineer

Company: Alphatec Spine
Location: Carlsbad
Posted on: August 7, 2022

Job Description:

Description

Develop and improve, with an emphasis on implementation, inspection methods, gages, process control techniques, standard operating procedures, inspection plans, test protocols and test reports to ensure safety, reliability and efficacy of new and current products and processes.

Essential Duties And Responsibilities

  • Lead management of Quality Engineering Deliverables for New Product Development
  • Lead Supplier Part Qualification for New Product Development
  • Technical interface with contract manufacturing
  • Lead Material Review Board (MRB)
  • Develop inspection methods, gages and associated drawings and procedures.
  • Support Design Control to ensure efficient effective and compliant new product launches
  • Support suppliers in performing IQ, OQ and PQ processes
  • Support Engineering Change Order Review.
  • Perform Design For Manufacturing (DFM)
  • Provide statistical support to analyze manufacturing processes and to recommend appropriate process controls for ensuring product conformance to specification.
  • Lead Risk Management efforts in accordance with ISO 14971
  • Perform Failure Mode and Effects Analysis (FMEA) for design and processes.
  • Support validations regarding sterilization, cleaning and shipping.
  • Participate in FDA, ISO and other regulatory audits.
  • 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.
    • Knowledge of both US and International medical device quality system requirements (e.g. 21 CFR Part 820, ISO 13485), and other applicable standards.
    • Extensive knowledge of Solid Works CAD software
    • Extensive knowledge of mechanical inspection methods and equipment
    • Extensive knowledge of SPC, DOE, probability and statistics
    • Ability to read, analyze, and interpret blueprints and GD&T
    • Ability to write reports and procedures
    • Ability to effectively interact with all levels of the organization
    • Working knowledge of lean principals and implementation
    • Ability to develop and maintain strong working relationships with internal and external customers and suppliers
    • Ability to solve complex problems to root cause and prevent re-occurrence (CAPA)
    • Technical writing of procedures and reports
    • Detail Oriented
    • Good decision making skills and judgment
    • The ability to execute plans/strategies to completion
    • Extensive knowledge of cleanability/sterilization (steam, EtO and Gamma) including dose mapping and dose audits.
    • Extensive knowledge of biocompatibility requirements
    • Must be able to travel up to 25% of the time

      Education And Experience
      • Minimum Bachelor's degree (BS) from a four-Year College or university in Mechanical, Biomedical, Industrial, Systems, or Manufacturing Engineering.
      • Six Sigma Black Belt, ASQ CQE (Certified Quality Engineer), ASQ CQA (Certified Quality Auditor) 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).

        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.

Keywords: Alphatec Spine, San Diego , Senior Quality Engineer, Engineering , Carlsbad, California

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