C. R. Bard, Inc.

  • Quality Engineer II- Capital

    Posted Date 2 weeks ago(2 weeks ago)
    Industry / Category
    Quality Engineer II/Quality Assurance
    Job ID
    Career Level
    Bard Medical
  • Overview

    BD Urology and Critical Care a BD Company is seeking to fill the position of Quality Engineer - Capital in Louisville, CO.  Formerly Bard Medical we are in the business of advancing lives and the delivery of healthcare.

    Summary of Position with General Responsibilities

    This position performs various quality-engineering functions and associated support tasks in developing knowledge and experience in the areas of Quality Assurance/Document Control/Design Control. This includes working to support Design Control projects as well as other duties in support of the Quality System, Design Control System, Document Control, Manufacturing, and the R&D/Product Development departments

    Essential Job Functions

    • Represents the Corporation, Division and Quality Department in a professional manner.
    • Participates on Project Team as Quality Representative. Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development.
    • Provides support for Project Teams or Quality Department as required such as generating RFS, ECR, PQR, etc. as required.
    • Creates and reviews Quality System Documents
    • Creates and reviews Product Documents
    • Creates and reviews Test Methods
    • Creates/reviews Protocols, Process and Product Validations, Stability Protocols
    • Provides work direction as required.
    • Creates and reviews documents required for Design History File.
    • Creates and reviews Risk Assessments such as FMEA, FMECA or FTA.
    • Performs Internal or Supplier Quality System Audits.
    • 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 or 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. May require consultation and direction to complete the essential duties and responsibilities.
    • Strong Data Management and Report Presentation Skills.
    • Advanced Microsoft Access and Microsoft Excel skills a must.
    • Ability to create and qualify pivot tables, pivot charts, macros, queries, forms, reports, etc. across applications.
    • Understands basic applied statistics.
    • Has fundamental knowledge of validation principles.
    • Comprehensive understanding of auditing principles; lead auditor experience a plus.
    • 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.
    • Ability to interpret Regulations, Corporate, Division and Department Procedures.

    Education and/or Experience

    • Bachelor of Science in Engineering, Engineering Technology, Science a minimum.
    • Minimum 5 years of experience with FDA regulated industry including 3+ years on product development programs.
    • American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.)


    Physical Demands

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


    Work Environment

     Normal office environment - noise level is quiet to moderate - frequent travel is required - when traveling to clinical sites or hospitals, work environment will be specific to the area under evaluation.

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