B. Braun

  • Technician, Prod Qual Excellnc

    Job Locations US-PA-Allentown
    Requisition ID
    2018-13611
    Company
    B. Braun Medical Inc
    # of Openings
    1
    Category
    Customer Service
    Position Type
    Regular Full-Time
    Shift
    8am to 5pm
    Site
    Corporate/Sales/ B. Braun of Canada/ BIS/ CeGat
  • Overview

    With a nationwide sales team and several manufacturing locations, B. Braun Medical has become a leading full-line supplier of healthcare products and services in the U.S. The company is committed to delivering innovative products and services with unmatched quality, superior technology, and cost-effectiveness, while maintaining environmental responsibility. Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. B. Braun employs over 4,500 people in the USA. B. Braun Medical Inc. began its operations in the USA in 1957. Initially, the company manufactured and sold disposable plastic syringes. During the 1980s and early 1990s, the company undertook several expansions and enlarged its product line of disposable medical devices. With the acquisition of McGaw, Inc. in 1997, including Central Admixture Pharmacy Services, Inc. (CAPS®), B. Braun dramatically broadened its product lines and services to U.S. customers.

     

    U.S. Facilities and Operations:

     

    Supporting product sales are a network of nationwide marketing and manufacturing locations. Bethlehem, Pennsylvania, is home to the U.S. Corporate Headquarters along with the marketing offices of the Hospital, Outpatient Markets (OPM), Renal Therapies, Vascular Interventional, International, and OEM Divisions. Central Admixture Pharmacy Services, Inc.(CAPS®) is also managed from this location. The nearby Allentown, Pennsylvania, facility manufactures Needle-free products, IV Safety Catheters, Anesthesia Systems, Introducers, Pharmacy Admixture products. Vascular products including Right Heart Catheters and Interventional Accessories are also manufactured in Allentown. The Irvine, California facility produces IV Solutions, Basic and Specialty Nutrition, Drug Delivery, and BTC products. Infusion Pump Systems are manufactured in Carrollton, Texas and IV administration and IV and Irrigation sets are produced in the Dominican Republic.

    Responsibilities

    Position Summary:

     

    The Technician, Product Quality Excellence is responsible for the collection, execution, and communication of customer complaint and other post-market surveillance records and reports. They work collaboratively with B. Braun’s Clinical & Technical Support team and manufacturing site quality assurance to ensure that all complaint files and regulatory reports are thoroughly understood, investigated, and responded to in a timely fashion in accordance with applicable regulations and standards.

     

    Responsibilities: Essential Duties

    • Performs initial review and assessment of complaint files and dispatches the investigations to the applicable manufacturing sites for all U.S. and Canadian medical device and pharmaceutical products.
    • Provides customers with instructions on how to handle and return complaint samples and performs follow-ups with reporters and manufacturing sites to ensure that all data required for thorough investigation and timely response is obtained.
    • Drafts Initial and Final Regulatory Reports including, but not limited to, MDRs, MPRs, and FARs as well as interim and final complaint response letters
    • Ensures all complaint files are ready for closure in a timely fashion in accordance with U.S. and Canadian regulations, ISO Standards and other applicable regulations and standards
    • Collects and aggregates data from post-market data sources for analysis including, but not limited to: customer complaint database, FDA MAUDE Database, and others.
    • Assist Analyst, Product Quality Excellence and Director, Product Quality Excellence in responding to inquiries from regulatory authorities.
    • Identify opportunities for continuous improvement in complaint handling and regulatory reporting processes and make recommendations to management.

    Expertise: Knowledge & Skills

    • General knowledge of product usage, medical terminology, and environmental regulations.
    • Familiarity with cGMP, CMDR, & MDD requirements for complaint management and regulatory reporting.
    • Excellent verbal, written, and interpersonal communication skills
    • Proficient in the use of computers and software including Microsoft Office (Excel, Word, PowerPoint)
    • Ability to interact with external customers in a polite and professional manner
    • Ability to exercise initiative and work independently
    • Ability to understand and perform basic data trending and/or statistical analysis

    #LI-GB1

    IN2017

     

    Qualifications

    Expertise: Qualifications - Experience/Training/Education/Etc

     

    Required:

    • Associates Degree and 3-5 years experience in a Quality Assurance or Quality Control role in a FDA regulated industry

    Desired:

    • Bilingual in German or French.
    • Previous Complaint Handling Experience

    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

     

    Equal Opportunity Employer Veterans/Disabled

     

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

    Other

    Responsibilities: Other Duties:

    • Performs other related duties as required by management

    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.

     

    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. The noise level in the work environment is usually moderate.

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