C. R. Bard, Inc.

  • Principal Risk Quality Engineer

    Posted Date 1 week ago(12/4/2018 4:48 PM)
    Job ID
    Career Level
  • Overview

    BD Urology and Critical Care is currently hiring a Quality Engineer – Risk Management.  This position is a growth opportunity based in Covington, GA.  Formerly Bard Medical, we have joined Becton-Dickinson a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. 

    Summary of Position with General Responsibilities

    The purpose of this position is to assist Quality Assurance Management in maintaining a department of qualified, motivated, and respected Quality Engineers. This includes assisting all Quality Engineers with the proper tools and guidance to be successful in performing their work, as well as providing them with a work environment conducive to personal and professional success. Additionally, the Quality Engineer functions as a subject-matter resource for Risk Management.

    Essential Job Functions

      • Represents the Corporation, Division and Quality Department in a professional manner.
      • Evaluates new methods and processes and review technical instructions to ensure compliance with Department and Division procedures and regulatory standards, with an emphasis in Risk Management. 
      • Provides Quality Assurance leadership for Quality Department or Project Teams.
      • Composes risk management documents, including design Failure Modes and Effects Analysis (FMEA) that comply with Risk Management standards.
      • Works with other functions on the development and incorporation of Risk Management during all design phases for new and/or product enhancements as well as developing and approving Risk Management Files.
      • Creates, reviews and approves Risk Assessments such as FMEA, FMECA or FTA.
      • Provides supervision to technicians and engineers
      • Creates, reviews and approves documents required for Design History File.
      • Participates on Project Team as Quality Representative.  Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development, as required.
      • Creates, reviews and approves Quality System Documents (CAPA, Audits), as required.
      • Creates, reviews and approves Product Documents, as required
      • Creates, reviews, and approves Protocols, Process and Product Validations, Stability Protocols, Software Validation documents, as required.
      • Analyzes process and product non-conformances and implement comprehensive corrective and preventive action plans, as required.
      • Performs Internal or Supplier Quality System Audits, as required
      • Performs Complaint review and investigation, as required.
      • Interfaces with manufacturing facility or other Division Facilities, as required.
      • Serves as Independent QA Reviewer for Design Reviews and participate in Phase Reviews, as required.
      • Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner, desired.

    Basic Qualifications

    • Comprehensive knowledge of quality systems and relationship to business.
    • Extensive knowledge of medical device regulation, industry or international standard, including risk management. Ability to perform engineering work of a broad nature with little or no direction.  Generally, receives guidance on novel or controversial problems.
    • Ability to understand Division and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency.
    • Participate in development of risk management documents.
    • Review activities related to Design Verification and Design Transfer of Medical Devices.
    • Ability to interface with regulatory bodies to present technical information.
    • Ensure proper justification of statistical analysis and hypothesis testing.
    • Understands basic applied statistics, statistical sampling plans, and statistical process control and advanced statistical methodologies such as DOE and Taguchi. Perform Data/Statistical analysis, as needed.
    • Ability to serve in leadership roles on projects or assignments.
    • Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understands team functions, leadership techniques and project management methodologies.
    • Broad knowledge of manufacturing processes.
    • Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience.
    • Understands Fundamentals of Engineering Principles.
    • Ability to effectively manage time.
    • Ability to handle multiple task assignments.
    • Ability to translate quality requirements into product specifications.
    • Ability to interpret Regulations, Corporate, Division and Department Procedures.

    Education and/or Experience

    • B.S. in Engineering, Engineering Technology, Science a minimum. 
    • 2 – 3 years of experience with FDA regulated industry.
    • American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred.

    Work Environment


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