B. Braun

  • Sr. Quality Systems Analyst

    Job Locations US-PA-Allentown
    Requisition ID
    2018-13342
    Company
    B. Braun Medical Inc
    # of Openings
    1
    Category
    Quality
    Position Type
    Regular Full-Time
    Shift
    8 am to 5 pm
    Site
    Allentown, PA
  • 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:

     

    Perform activities related to Quality Assurance function to ensure timely completion of the functional tasks. Knows and applies quality concepts, practices and company procedures in the area of quality assurance, audit processing, and regulatory responsibilities. Preparations for audits and assisting in the approval, monitoring, and evaluation of the effectiveness of corrective actions identified within the quality system. Also, establish guidelines and requirements from Quality Assurance perspective in supporting special projects.

     

    Responsibilities: Essential Duties

    • Administrates and facilitates quality systems process in accordance with company policies and procedures. 
    • Responsible for leading root cause investigations, documenting results, and overseeing corrective action for product/process quality issues resulting from a variety of technical problems of moderate to complex scope.
    • Conduct periodic departmental internal audits and verifications to ensure compliance to applicable regulations and inspectional readiness.
    • Support site supplier quality management activities to ensure compliance to applicable regulations.
    • Serve as liaison for Allentown Operations Quality organization for communications to B.Braun distributors and/or OEM customers for quality issues including but not limited to audits observations, investigations and CAPAs.
    • Serve as backroom support for B.Braun distributors and/or OEM customer audits, including data summarization and analysis.  As required, serve as B.Braun distributors and/or OEM audit host.
    • Provides support during regulatory inspections.
    • Support the company audit program (B.Braun Distributors and Customer) to ensure timely and effective corrective actions are developed, implemented and verified to resolve audit observations while maintain compliance with applicable FDA Quality System Regulations and ISO standards.
    • Assists in timely completion of all Customer/Vendor/Supplier Questionnaires and Submissions.
    • Ensuring that the quality system standards imposed by customers are not overlooked, yet do not compromise or conflict with internal B. Braun Requirements.
    • Interface effectively with Management personnel in Engineering, Manufacturing, Regulatory Affairs and other technical disciplines.
    • Support the introduction of new Corporate Quality System initiatives into the B Braun Plant Quality System.
    • Provides overall direction and expertise for policies in compliance with current GMP’s and corporate policy.
    • Stay abreast of evolving regulatory trends that are relevant and ensure that appropriate action is initiated and communicate these trends to applicable personnel.
    • Identify quality issues and implement corrective and preventative actions.
    • Ensure compliance to FDA regulations, ISO standards, Medical Device Directives (MDD), and Canadian Medical Device Regulations (CMDR).
    • Ability to work effectively with external customers and/or suppliers to author Quality Agreements, which will define both the purchaser’s and suppliers’ respective obligations to the quality system elements that relate to Quality.
    • Generate and review site procedures in accordance with regulatory requirements .
    • Performs other related duties as required by management. 

    Expertise: Knowledge & Skills

    • Knowledge of Medical Device Quality Systems Regulations (21 CFR 820), ISO 13485 and Medical Device Directive (MDD) requirements.
    • Excellent computer and PC skills including experience with MS Office and databases
    • Ability to make verbal presentations to both small and large groups at a variety of levels both inside and outside of the company.
    • Capability to act effectively as a member of a team to resolve problems.
    • Ability to simultaneously work on several projects with the flexibility to reprioritize in a minimum amount of time.
    • Ability to effectively work with all functional groups. 
    • Ability to investigate regulatory issues.
    • Project management skills
    • Excellent oral and written skills.

    Qualifications

    Expertise: Qualifications - Experience/Training/Education/Etc

     

    Required:

    • Bachelor Degree in an applicable field (i.e. Business, Engineering) or an equivalent combination of education and experience
    • 4 – 5 years relevant work experience
    • Experience in auditing for performing and hosting internal audits, supplier audits, or FDA/ISO regulatory inspections
    • Experience with cGMP’s, and FDA guidelines

    Desired:

    • Certified Quality Auditor (CQA) preferred
    • ASQ membership preferred
    • 1-3 years experience with Change Management

    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:

     

    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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