C. R. Bard, Inc.

  • Quality Engineer II

    Posted Date 1 month ago(10/10/2018 4:48 PM)
    Job ID
    Career Level
    Bard Peripheral Vascular
    US-UT-Salt Lake City
  • Overview

    This position develops implements and improves new and existing product quality requirements.

    Summary of Position with General Responsibilities

    This position will assist with complaint investigations, quality management remediation efforts and other quality engineering activities as required.

    Essential Job Functions

    • Provide Quality Engineering representation on Product Development Teams.
    • Initiate new or revised documentation
    • Lead cross-functional teams to develop risk assessment.
    • Develop physical and functional test methods to ensure specifications are met.
    • Write, review and approve design verification and validation protocols and reports.
    • Develop processes 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 on manufacturing processes.
    • Provide technical direction during design transfer activities.
    • Conduct complaint investigations.
    • Participate and provides input to training on department/division procedures, and policies.
    • Coordinate and lead internal and supplier audits.
    • Develop and implement procedures to comply with corporate and industry standards.
    • Understand and follow company procedures on regulatory requirements.
    • Provide support to the regulatory department in writing technical submissions.
    • Provide positive example and actively promotes compliance to all standards.
    • Maintain a professional working relationship with internal and external customer and support staff.
    • Prepare and present project updates and technical discussions.

    Basic Qualifications

    • Ability to make and present engineering decisions
    • Strong interpersonal skills
    • Demonstrated Project Management skills
    • Advanced statistics
    • Understanding and application of DOE
    • Ability to lead cross functional teams
    • Engineering cost analysis
    • Ability to analyze and optimize manufacturing and quality systems
    • Advanced product, design & prototyping skills
    • Ability to create and provide training
    • Software application skills
    • Advanced problem solving skills
    • Ability to create, review and coordinate test protocols and reports
    • Ability to generate engineering proposals
    • Oral and written presentation skills
    • In-depth knowledge of regulatory requirements
    • Ability to develop and control a budget
    • Ability to manage technical personnel
    • Ability to perform design review functions
    • Must read, write and understand English. 
    • Must be detailed in handling information/data. 

    Education and/or Experience

    Prefer a minimum of 6 years’ experience in the medical field or closely related industry or a Master’s Degree plus three years. Quality Engineering Certification (ASQ) or equivalent. Extensive knowledge of FDA GMP/GLP, Medical Device Directive, ASTM, AAMI, CEN and ISO.

    Physical Demands

    While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment.  The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. 

    Work Environment

    Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

    While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment.

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