C. R. Bard, Inc.

  • Advanced Quality Engineer (AQE) II / Sr. Advanced Quality Engineer (AQE)

    Posted Date 2 weeks ago(4/2/2018 12:55 PM)
    Industry / Category
    Medical Device - Quality Assurance
    Job ID
    Career Level
    BDI Surgery
  • Overview

    BD Interventional’s Surgery worldwide business unit, located in Rhode Island, is a leading developer, manufacturer, and marketer of innovative, life-enhancing medical technologies. For the past 40 years, we have stood out as the market leader in providing solutions in soft tissue reconstruction including products for hernia repair, specialized surgical procedures, fixation and biologic implants. In addition to this extensive suite of products, our BioSurgery business is delivering a growing line of enhanced sealants and hemostatic products to complement surgical techniques across, thoracic, cardiovascular and other surgical specialties.   

    Our company has a strong tradition of developing our employees to learn, grow and excel.  We are continually building our team with qualified, team oriented individuals to enhance the success of our company.

    The Surgery business unit is situated in a central location, surrounded by a scenic coastline with easy access to T.F. Green Airport, AMTRAK Train Stations and Route 95, a major highway connecting to Providence, Connecticut, Boston and New York City within a short amount of time.

    Summary of Position with General Responsibilities

    This position assures that new product designs and the processes for manufacturing them meet all Corporate and Divisional requirements with respect to safety and efficacy.  This individual will be an active team member and cross-function collaborator on new product development and product enhancement project teams for implantable medical devices. In addition, 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 BDI Surgery’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 devices.
    • 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 Engineering.
    • 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.
    • Special projects as assigned.

    Basic Qualifications

    • Bachelor or Master of Science Degree in Engineering or Technical Sciences.
    • AQE II: With B.S., minimum of 3 years’ experience / with M.S., minimum 2 years’ experience in Quality Engineering discipline including design controls, product/process validation, risk management, and technical problem solving.
    • Sr. AQE: With B.S., minimum of 5 years’ experience / with M.S., minimum 4 years’ experience in Quality Engineering discipline including design controls, product/process validation, risk management, and technical problem solving.
    • Applied Knowledge of the requirements of FDA QSR, ISO13485 and ISO 9001.
    • Experience in medical device including broad knowledge and use of disposables or implantables.
    • Good oral and written communication skills.
    • Ability to travel up to 20%.
    • A high level of competence in statistical analysis techniques.
    • Strong Design Control understanding from concept to launch; including post-market activities, complaints analysis, failure investigations, and CAPAs.

    Additional Desirable Qualifications Skills and Knowledge

    • Prior experience interacting with Surgeons a plus.
    • Prior experience with combination products and absorbable technologies a plus.

    Education and/or Experience

    BD Interventional and Becton Dickinson are Affirmative Action/Equal Opportunity Employers, M/F/D/V. VEVRAA Federal Contractor.



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