B. Braun

  • Supplier Quality Engineer

    Job Locations US-PA-Center Valley
    Requisition ID
    2019-13824
    Company
    Aesculap Inc
    # of Openings
    1
    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:

    Provide quality management of Aesculap external and internal suppliers; monitor the quality parameters of the assigned suppliers, assist with validations and report performance on a regular basis. Works with St. Louis Operations, Supply Chain, Tek Park R&D Engineering, Aesculap AG and Product Management Teams, to proactively lead quality initiatives with suppliers including identifying and implementing improvements regarding their quality, performance and cost.

     

    Responsibilities: Essential Duties

    Principal Duties Responsibilities: 

    • Works directly with Aesculap Supply Chain to develop and control suppliers.
    • Assists in change management, SCARs and escalations for supplier issues.
    • Assists in selection and qualification of new suppliers in cooperation with other departments.
    • Assess the impact of reported quality changes on the status of the suppliers, materials and coordinate the required corrective actions as needed. 
    • Lead proactive quality initiatives with suppliers to identify and implement improvements regarding their quality, performance, and cost.
    • Participates in periodic review of supplier quality files.
    • Works with suppliers on Quality surveys and supports Quality Agreements.
    • Assists on supplier process and equipment validations.
    • Completes customer generated supplier surveys as required.
    • Assists with Risk Analysis per ISO 14971 on FMEAs for inspection, production, and design.
    • Reviews Supplier Product Evaluations and performs product assessments.
    • Creates Quality System documents to support ISO 13485.
    • 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 may require 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.  
    • 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 with limited supervision.

    Supervisory Responsibilities: N/A

    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. 

     

    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, Life Science, Mathematics or equivalent required. Master’s degree in Engineering or Life Science preferred.
    • Must have 2+ years’ experience in Medical Device Quality Assurance with BS/BA or 1+ years with MS/MA required.
    • Auditing experience (can include either internal or external auditing) preferred.
    • CQA (Certified Quality Auditor) or other equivalent certification a plus.
    • Knowledge of Change Control, Deviation Handling, Production/Process controls, and SCAR is preferred.
    • Process validation documentation creation experience a plus.
    • Prior Supplier Quality Assurance preferred.
    • Must have strong Quality and Compliance experience in FDA regulated industry.
    • Must have understanding of FDA GMPs, ISO 13485, and ISO 14971.

    Desired:

    • Proficiency in German highly desired.   

    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 20 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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