B. Braun

  • Quality Engineer, Senior

    Job Locations US-MO-Hazelwood
    Requisition ID
    2019-14181
    Company
    Aesculap Inc
    # of Openings
    1
    Category
    Quality
    Position Type
    Regular Full-Time
    Shift
    8:00 a.m. - 5:00 p.m.
  • Overview

    Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Through close collaboration with its customers, Aesculap provides advanced technologies for general surgery, neurosurgery and closure technologies. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver products and services that improve the quality of patients’ lives.

    Responsibilities

    Position Summary:

     

    Provide Quality Engineering leadership to operations for quality activities and maintain oversight of receiving, inspection, distribution, repackaging & labeling activities for quality compliance, while assuring that products and process are in accordance with company policies and procedures.

    Together with the Operations, Technical Services and QC teams, the incumbent of this position will be accountable for the performance against key business objectives such as safety, quality, and compliance. The incumbent will drive peers to manage performance of equipment, systems, and processes; and will work to improve the output, efficiency or quality of the associated purchased and distributed products.

     

    Responsibilities: Essential Duties

    • Establishes quality standards for products and processes and suggest modifications meant to prevent defects in final products.
    • Works closely with cross-functional teams, including product design, product management and operations, to identify and mitigate quality risks.
    • Ability to lead quality initiatives as the project manager to timely completion
    • Audits operational processes to ensure that established quality standards are met.
    • Conducts root cause analysis for defects, non-conformities or other quality failures.
    • Review and approve product / process deviations or rework documentation.
    • Develop Quality & Deviation Plans as needed.
    • Perform internal audits.
    • Knowledge of Statistics and process controls.
    • Supports Supplier Quality in monitoring supplier performance.
    • Perform product and process validation activities including protocol development, execution, report writing as needed.
    • Acquire and analyze data using appropriate quantitative methods to facilitate process analysis and improvements.
    • Use problem solving techniques to conduct CAPA, complaint investigation, root cause analysis, and quality improvement when necessary.
    • Must comply with applicable ISO and FDA regulations as stated in Quality Manual
    • Must embody the Company’s Vision, Mission and Values
    • Other duties may be assigned

    Secondary or peripheral job functions: 

    •  Must be able to travel by air and car, and work occasional weekends.
    • Requires excellent written and interpersonal communication skills.
    • This position requires the handling of instruments that may have been contaminated by blood or other bodily fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees.
    • Proficient in the use of Microsoft Excel, Power Point and Word.
    • Uses professional concepts in accordance with company objectives to help solve complex problems in creative and effective ways, complete projects as assigned and achieve goals.
    • Coordinates and supports team activities using creative thinking and organizational skills.
    • Works well in a team environment with limited supervision.

     

    Supervisory Responsibilities:

    • N/A

     

    Expertise: Knowledge & Skills

    • Language Skills: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, and/or boards of directors.  
    • Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
    • Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

    Qualifications

    Expertise: Qualifications - Experience/Training/Education/Etc

      

    Required:

    • BS in Engineering preferred, other technical degrees will be considered with relevant experience.
    • CQE and CQA certifications preferred.
    • 5+ years Quality Engineering experience with a Medical Device Company required.
    • Must have understanding of FDA GMPs, ISO13485, and ISO14971.
    • Knowledge of statistics and process controls.
    • Project experience in UDI and labeling control preferred.
    • Occasional business travel required, Ability to work non-standard schedule as needed

    Desired: N/A

     

    While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

     

     

    Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.

     

    Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

     

    Other

    Responsibilities: Other Duties

     

    The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

     

    Physical Demands:

     

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

    While performing the duties of this job, the employee is regularly required to sit and talk or hear.  The employee frequently is required to use hands to finger, handle, or feel and reach with hands and arms.  The employee is occasionally required to stand and walk.  The employee must occasionally lift and/or move up to 20 pounds. 

     

    Work Environment:

     

    The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  This position could require the handling of instruments that may or may not have been contaminated by blood or other body fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees. The noise level in the work environment is usually moderate.

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