C. R. Bard, Inc.

  • Quality Engineer I

    Posted Date 3 weeks ago(5/3/2018 12:55 PM)
    Industry / Category
    Quality Engineer/Engineer
    Job ID
    2018-11521
    Career Level
    experienced
    Division
    Bard Medical Division
    Relocation
    No
    Location
    US-GA-Covington
  • Overview

    Bard has joined BD, together advancing the world of health.  BD Urology & Critical Care, formerly Bard Medical, is looking to fill a Quality Engineer  position at our Covington, GA division headquarters. 

    Summary of Position with General Responsibilities

    This position performs various quality engineering functions by applying knowledge of technical principles related to Corrective Action and Preventive Actions (CAPAs). This includes working to support various manufacturing sites and assist in the trouble shooting and documentation of internal non conformances and customer complaints. The position requires leading projects and interaction with cross functional team members including Sales and Marketing, Quality Assurance, Regulatory Affairs and the R&D/Product Development departments.

    Essential Job Functions

    • Creates and reviews Risk Assessments such as FMEA, FMECA or FTA.
    • Perform investigations and document findings related to customer complaints and internal non-conformances.
    • Function as the Quality Representative for the Project Team assigned to quality issues and documentation of those issues. Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development.
    • Provides leadership for Project Teams assigned to product quality issues and documenting the investigation, evaluation and decision relating to these issues.
    • Creates and reviews Quality System Documents including trend analysis and CAPA determination.
    • Track the implementation and effectiveness of committed corrective and preventive actions.
    • Analyze problems occurring in the assembling, processing and testing of products.
    • Creates/reviews Protocols, Process and Product Validations, Stability Protocols.
    • Performs Internal or Supplier Quality System Audits.
    • Creates and reviews documents required for Design History File.
    • Ensures compliance to Department and Division procedures.
    • 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.
    • Interfaces with manufacturing facility and other Division Facilities.
    • Travels as required by the above duties and responsibilities.

     

    Basic Qualifications

    • Ability to perform detailed engineering work under direction of a Senior Engineer or Quality Management.

    • Understands basic applied statistics.

    • Ability to participate on teams and maintain positive work environment with those teams.

    • Good communication skills (verbal, written, and presentation)

    • Understands Basic Fundamentals of Engineering Principles

    • Ability to effectively manage time

    • Ability to handle multiple task assignments.

    • Ability to translate quality requirements into product specifications.

    • May require consultation and direction to complete the essential duties and responsibilities.

     

    Education and/or Experience

    • BS in Engineering, Engineering Technology, Science a minimum
    • American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred
    • Minimum 1 years of experience with FDA regulated industry

    Physical Demands

    Employee may be required to sit, bend, stoop, use keyboard, see, talk and hear.  May occasionally lift objects of 10 to 25 lbs.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

     

    Work Environment

    • Office and manufacturing environments
    • May include visits to clinical sites or hospitals. #LI-CW1
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