C. R. Bard, Inc.

  • Quality Manager

    Posted Date 5 months ago(1/22/2018 11:11 AM)
    Industry / Category
    Quality Manager
    Job ID
    Career Level
  • Summary of Position with General Responsibilities

    Responsible for the general management of the Delran Operations Quality Assurance function to assure compliance to established standards of corporate objectives and regulated agencies for industry (ISO and FDA).  Responsible for the planning, development, and implementation of quality systems that support the Delran Ops and Davol business objectives.  Appointed as FDA/ISO management representative for the site. 

    Essential Job Functions

    • Support the facility as a Quality Management System (QMS) Representative.
    • Development, implementation, and maintenance of quality systems to assure FDA, and ISO compliance.
    • Provide leadership in the implementation and execution of Quality Systems activities execution of the programs and processes related to CAPA, Management Reviews, Supplier Quality Management, (Scars and Inspection) Management Reviews, Non Conforming and internal audits and training activities, validations etc.
    • Optimize quality systems to effectively identify measure and reduce cost of quality activities, where applicable.
    • Identify, support, and develop departmental resources to achieve business and quality objectives.
    • Coordinate all facility audits (FDA, ISO, Corporate, Customer).
    • Review and approve Engineering changes to product; processes and materials.
    • To promote and support multi-discipline teamwork, i.e., activities that support the Delran management system inclusive of Davol and Bard Puerto Rico strategic initiatives and tactical plans.
    • Coordinate management review periodically to assess the effectiveness and suitability of the quality management system.
    • Supervises Quality Engineering, and QC Inspectors in support for incoming, in-process and final inspection and batch record product release.
    • Applies problem-solving skills to the corrective and preventative action (CAPA) process to eliminate problem root cause(s).
    • Develops strong partnering relationships with Engineering, Technology, Suppliers and the R&D community
    • Performs other duties assigned by his supervisor.


    Basic Qualifications

    • Working knowledge of US FDA and International regulations governing the medical device industry (i.e. QSR, GMP, MDR, and ISO 13485
    • Knowledge of fundamental quality systems principles such as CAPA, Failure Investigation and Management Reviews
    • Textile manufacturing experience is a plus.
    • Leadership, supervisory and development skills
    • Excellent interpersonal skills including the ability to interface and communicate effectively at all levels, both inside and outside the organization
    • Demonstrated ability to plan and manage multiple projects, including the ability to manage the resolution of technical and tactical issues
    • Demonstrated ability to understand, apply and analyze statistical controls, process validation and controls, and Inspection and Testing Methods validations
    • Must have good communication skills both, oral and written - bilingual (English/Spanish) and plus.
    • Team work oriented

    Education and/or Experience

    • Minimum of a four year degree in the work related sciences (Mechanical engineering, Science or other technical field).
    •       Minimum of 3-5 years experience working in a textile facility
    •       Minimum of 3- 5 years experience working in a production operating environment
    • Minimum of 5-7 years experience in a federally regulated industry to include Quality Assurance and/or Regulatory Affairs.
    • Minimum five years supervisory experience

    Physical Demands

    • Hours of operation are flexible and vary depending on job requirements. Typical workweek is 40 hours with additional/variable hours for specific work periods and projects. Specific works days and hours are flexible and may change with advance notice
    • The nature of the work requires exposure to chemicals, noise. Exposure to machinery and non-ionizing radiation

    Work Environment


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