C. R. Bard, Inc.

  • Quality Engineer II

    Posted Date 2 weeks ago(8/3/2018 10:52 AM)
    Industry / Category
    Medical Device/ Quality
    Job ID
    2018-11922
    Career Level
    experienced
    Division
    Bard Peripheral Vascular
    Relocation
    No
    Location
    US-AZ-Tempe
  • Overview

    Becton, Dickinson Interventional (BDI) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 65,000 people across 50 countries around the world. Founded more than 100 years ago, BDI pioneered many devices that are cornerstones of modern healthcare.  BD - PI is the vascular division within BDI and focusses on interventional products for peripheral arterial disease (PAD), end stage renal disease (ESRD), and Cancer.

     

    We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness, respect, and feel valued, acknowledged and rewarded.

     

    #LI-SF1

     

    Be Your Best at BD-PI – and ultimately, you can have an impact on the lives of people around the world.

    Summary of Position with General Responsibilities

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

    Essential Job Functions

    1. Provide Quality Engineering representation on Product Development Teams.
    2. Initiate new or revised documentation
    3. Lead cross-functional teams to develop risk assessment.
    4. Develop physical and functional test methods to ensure specifications are met.
    5. Write, review and approve design verification and validation protocols and reports.
    6. Develop processes validation requirements (IQ, OQ, PQ) and equipment qualifications.
    7. Conduct and /or coordinate testing outlined in protocols and test methods.
    8. Perform process improvement, control and monitoring on manufacturing processes.
    9. Provide technical direction during design transfer activities.
    10. Conduct complaint investigations.
    11. Participate and provides input to training on department/division procedures, and policies.
    12. Participate in project planning, budgeting, scheduling and tracking.
    13. Coordinate and lead internal and supplier audits.
    14. Develop and implement procedures to comply with corporate and industry standards.
    15. Understand and follow company procedures on regulatory requirements.
    16. Provide support to the regulatory department in writing technical submissions.
    17. Provide positive example and actively promotes compliance to all standards.
    18. Maintain a professional working relationship with internal and external customer and support staff.
    19. Prepare and present project updates and technical discussions.

    Basic Qualifications

    1. Ability to make and present engineering decisions
    2. Strong interpersonal skills
    3. Demonstrated Project Management skills
    4. Advanced statistics
    5.  Understanding and application of DOE
    6. Ability to lead cross functional teams
    7. Engineering cost analysis
    8. Ability to analyze and optimize manufacturing and quality systems
    9. Advanced product, design & prototyping skills
    10. Ability to create and provide training
    11. Software application skills
    12. Advanced problem solving skills
    13. Ability to create, review and coordinate test protocols and reports
    14. Ability to generate engineering proposals
    15. Oral and written presentation skills
    16. In-depth knowledge of regulatory requirements
    17. Ability to develop and control a budget
    18. Ability to manage technical personnel
    19. Ability to perform design review functions
    20. .Must read, write and understand English. Must be detailed in handling information/data.             

    Additional Desirable Qualifications Skills and Knowledge

    Prefer a minimum of 6 years experience in the medical field or closely related industry or a Masters Degree plus three years.

    Education and/or Experience

    A minimum of a Bachelors degree in a technical field.

    Prefer a minimum of 6 years experience in the medical field or closely related industry or a Masters 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

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

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