C. R. Bard, Inc.

  • Senior Advanced Quality Engineer (AQE)

    Posted Date 1 month ago(10/30/2018 11:31 PM)
    Job ID
    Career Level
    BDI Surgery
  • Summary of Position with General Responsibilities

    To assure that new product designs and the processes for manufacturing them meet all Corporate and
    Divisional requirements with respect to safety and efficacy. Be an active team member and crossfunction
    collaborator on new product development and product enhancement project teams for
    implantable medical devices. Be an active team member for investigating quality complaints,
    examining non-conformances and executing CAPAs.


    Essential Job Functions

    Product Development:
     Provide Technical guidance to Quality Engineers, Quality Technicians, and Inspectors.
     Development of Test Protocols and Final Report to support Regulatory 510K, PMA, CE mark and
    International registrations.
     Support Pre-Concept Front End Product Innovation Process activities for new technologies.
     Lead Quality Engineering Projects to improve Quality systems and Procedures.
     Development of the DFMEA, coordinating input from the other Design Sub-team members.
     Development of the Final Design Verification Protocol and the subsequent Final Design Verification
    Report including an analysis of all data and a decision on design acceptability.
     Development of the Design Validation Protocol and the subsequent Design Validation Report
    including an analysis of all data and a decision on design acceptability.
     Provide input into the project Design Input Summary (DIS), Product Performance Specification
    (PPS), Product Development Plan (PDP), and applicable design control documents as defined per
    Davol’s product development process.
     Determine the degree of Biocompatibility testing required as per ISO10993 and company procedures.
    Co-ordinate the testing at an outside lab and document results.
     Develop or assist in development of inspection and test methods per product specifications.
     Develop test protocols and release a final report on Shelf Life and Stability Studies in support of
    expiration dating.
     Perform test method validations to ensure accuracy, precision, selectivity, sensitivity, stability, and
    reproducibility of analytical or physical test methods used to assess the safety and efficacy of device s.
     Develop shelf life and stability test protocols and reports as required.


    Process Development:
     Develop and document the Control System for the manufacture of new products including Inspection
    Plans for the inspection of components, sub-assemblies and final product.
     Support the development of manufacturing control plans for internal and outsourced processes.
     Support (or lead) development of the PFMEA.
     Perform and/or Support Process Development Studies to determine the acceptability
    of new processes or equipment.
     Design and qualify inspection test methods and equipment.
     Provide Quality Engineering Support to outsourced analytical laboratories and manufacturing
    facilities to ensure compliance with applicable requirements of 21CFR 820, 210, 211; cGMP’s, and
    ISO13485:2003 requirements.
     Lead supplier part qualification activities including mold qualification and DOEs.
     Support Process Transfers to the Production facilities.


     Make dispositions of rejected nonconforming components and products; conduct
    MRB action when required.
     Organize and generate detailed quality information reports to show trends and the
    impact of process improvements.
     Support Process Transfers to the production facilities.
     Conduct other Quality Control Projects as assigned by the Manager of Advanced Quality
     Support the development and effective implementation of Corrective and Preventive Action Plans to
    resolve quality non-conformances.
     Perform DOE’s and other statistical analysis to support product and process optimization or
    determine causes of process variation. Initiate corrective actions as required.
     Provide technical support to resolve quality problems in development, pilot, manufacturing or with
    suppliers as warranted.
     Support goals of the Quality Assurance Department.

    Key Relationships
    Internal Relationships:
    - Quality & Regulatory Affairs Personnel
    - Production Supervisors & Managers
    - Manufacturing & Ind. Engineers
    - Product Managers
    - Product Development Engineers
    - Buyers
    - Schedulers
    External Relationships:
    - Suppliers/Subcontractors
    - Customers
    - Other Bard Divisions


    Scope and Impact of Position:
    The scope of the work is across all phases of development activity, including vendors and
    suppliers. The work has an impact on product function, product release dates, product
    quality, and product costs.

    Basic Qualifications

     B.S. or M.S. in Mechanical Engineering, Biomedical Engineering, Technical science, or
    equivalent combination of Bachelors Degree and related work experience.
     A high level of competence in Quality Technology, statistical techniques, and six sigma tools
    including: sampling plans, process capability analysis, gage R&R, hypothesis testing, analysis
    of variance, regression, and design of experiments.
     Strong Design Control understanding from concept to launch; especially in post-market
    activities (including complaints, failure investigations, and CAPAs).
     Applied Knowledge of the requirements of FDA QSR, ISO13485and ISO 9001.
     With B.S., minimum of 5 years experience in Quality Engineering discipline including design
    controls, product/process validation, risk management, and technical problem solving
     With M.S., minimum 4 years experience in Quality Engineering discipline including design
    controls, product/process validation, risk management, and technical problem solving
     Travel flexible
     Good oral and written communication skills.
     Ability to work with and motivate people.

    Work Environment


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