B. Braun

  • Quality Assurance Complaints Analyst

    Job Locations US-PA-Center Valley
    Requisition ID
    2019-13820
    Company
    Aesculap Inc
    # of Openings
    5
    Category
    Quality
    Position Type
    Regular Full-Time
    Shift
    8 a.m. to 5 p.m.
    Site
    Aesculap
  • 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:

    The Quality Assurance Complaints Analyst on the Post Market team will participate in complaint and MDR handling activities for the purpose of ensuring compliance with US and international regulatory compliance and medical device reporting requirements, as well as improving the customer experience.

     

    Responsibilities: Essential Duties

    • Receive and process complaints escalated from internal and external customers related to products manufactured and or distributed and serviced by Aesculap in a manner consistent with all laws and regulations for medical devices.
    • Maintains the Medical Device Reporting system using FDA eMDR (WebTrader) gateway.
    • Responds to FDA’s Request For Information (RFI) on any required MDRs
    • Generate and analyze customer feedback data to improve product reliability and performance for our customers.
    • Conduct follow up investigation on potential medical events including contacting hospital personnel
    • Assess complaint information for determination of adverse event reporting and/or vigilance reporting.
    • Monitors, evaluates and reports on complaint Product and triggers internal investigations (ATS).
    • Possess understanding of risk management concepts and is capable of assessing product risks.
    • Identify critical product issues and escalate through the quality system for Field Action, Corrective and Preventive Action (CAPA), Supplier Corrective Action.
    • Oversight of critical Post Market projects and routinely share project goals, status, requirements, and deliverables to management.
    • Build key relationships with Product Managers to keep abreast of new technologies and product changes.
    • Communicate, work cross-functionally and consult frequently with Manufacturing, Operations, Service, Sales, Research and Development, Regulatory and Marketing.
    • Ensure completion of key deliverables.
    • Must embody the Company’s Vision, Mission and Values
    • Other duties may be assigned

    Expertise: Knowledge & Skills

     

    Language Skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.  Ability to write routine reports and correspondence.  Ability to speak effectively before groups of customers or employees of organization.  Ability to speak German and/or Spanish preferred.  

     

    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:

    • High School Diploma or equivalent in combination with 2+ years of Complaint Handling and/or MDR/Vigilance experience is required.
    • Bachelor’s degree in Life Science or Engineering discipline preferred.
    • BSN/RN with Licensure preferred (Prior Complaint Handling/MDR not required with this skillset).
    • Knowledge and application of complaint handling regulations, medical device reporting and other quality standards.
    • Knowledge of 21 CFR Part 820, Quality Systems Regulations.
    • Knowledge of 21 CFR Part 803, Medical Device Reporting.
    • Ability to drive results, foster teamwork, handle pressure, and provide feedback
    • Able to make judgment calls using combination of knowledge of regulations, knowledge of device technology, clinical experience, and critical thinking.
    • Ability to perform detail-oriented work with a high degree of accuracy.
    • Proven ability to work cross-functionally in a team based environment.
    • Proficient in MS Office Suite of products.
    • Willingness to be flexible and adaptable to changing priorities.
    • Excellent oral and written technical communication skills.
    • Effective analytical and problem solving skills.

    Desired:

    • Background in surgical Instruments, sterilization and Implants highly desirable.
    • Knowledge of SAP preferred.
    • Knowledge of BDocs Preferred.
    • Full understanding of Good Manufacturing Practice (GMP) preferred.

    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 Minorities /Women/ Veterans/Disabled

     

    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:

    • 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 50 pounds.

    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:

    • 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 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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