C. R. Bard, Inc.

  • Sr Quality Engineer -Product Development

    Posted Date 4 weeks ago(9/18/2018 4:27 PM)
    Job ID
    2018-12135
    Career Level
    experienced
    Division
    BPV Project
    Relocation
    No
    Location
    US-IL-Carol Stream
  • Overview

    This position will support development of new products and processes for medical devices within the Research and Development department and support transfer of the developed processes and products into Operations.

    Summary of Position with General Responsibilities

    The position provides leadership and facilitation of Quality System activities associated with internal Bard design control procedures, 21 CFR 820 and 803, ISO 9001-13485, and MDD.

    Essential Job Functions

    • Provide Quality Engineering representation on Product Development Teams.
    • Participate in design of experiment (DOE) activities to evaluate developed processes
    • Develop and validate physical and functional test methods to ensure specifications are met.
    • Write, review and/or assist in performance of design verification and validation protocols and reports.
    • Develop process validation requirements (IQ, OQ, PQ) and equipment qualifications.
    • Conduct and /or coordinate testing outlined in protocols and test methods.
    • Perform process improvement, control and monitoring of manufacturing processes.
    • Initiate/review new/revised Quality System documentation and track through approval cycles and implementation.
    • Participate on cross-functional teams to develop risk assessments and failure mode analyses
    • Provide technical direction during design transfer activities.
    • Participate in and provide input to training on BPV department/division procedures and policies.
    • Identify, implement, and monitor procedures and systems to support 21CFR§820, ISO 13485, and the European Medical Device Directive.
    • Understand and follow company procedures on regulatory requirements.
    • Provide positive example and actively promote compliance to all standards.
    • Maintain a professional working relationship with internal and external customers and support staff.
    • Participate in project planning, budgeting, scheduling and tracking.
    • Participate in internal and supplier audits.
    • Conduct complaint investigations.
    • Develop and implement procedures to provide easy to follow instructions.
    • Prepare and present project updates and technical discussions.
    • Travel as required by the above duties and responsibilities. Travel generally <25% but will be greater during the first year of service as needed for training purposes.

    Basic Qualifications

    To perform this job successful, an individual must be able to perform each essential duty satisfactorily.  The requirements listed in this section and 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.

     

    • Working knowledge of design controls, FDA GMP/GLP, Medical Device Directive, and ISO.
    • Ability to work on cross functional teams
    • Ability to make and present quality engineering decisions
    • Strong interpersonal and writing skills
    • Ability to create, review and coordinate test protocols and reports
    • Experience in comparative statistics and design of experiments
    • Ability to analyze and optimize manufacturing and quality systems
    • Basic product design & prototyping skills
    • Ability to create and provide training
    • Software application skills including Word, Visio, Excel, Powerpoint and Minitab or equivalent software
    • Problem solving ability
    • Strong oral and written presentation skills
    • Ability to interpret Federal Regulations and Corporate, Division and Department Procedures.
    • Must read, write and understand English.
    • Must be detailed in handling of information/data.

    Education and/or Experience

    • A minimum of a BS in a scientific discipline (Engineering, Engineering Technology, Chemical/Biological or equivalent). 
    • Four years experience in the medical field or closely related industry.
    • Demonstrated knowledge and experience in design controls, validations and qualification protocol generation, execution and reporting
    • ASQ certification (e.g. CQE, CQA, etc.) preferred
    • Proficiency in Microsoft Word and Excel

    Physical Demands

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    While performing the duties of this job, the employee is regularly required to sit, talk or hear.  The employee is frequently required to use hands to touch, handle or feel.  The employee is occasionally required to stand and reach with hands and arms and lift or move up to 25 lbs.  Vision requirements include the ability to see and interact with computer as well as close vision.

    Work Environment

    This work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    This position works in an office and manufacturing environment.  The noise level in the work environment is quiet to moderate. May include manufacturing or lab environment and certain work areas contain radioactive or hazardous chemicals. 

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