B. Braun

  • Supervisor, Quality Systems, Change Control & Document Control

    Job Locations US-PA-Allentown
    Requisition ID
    2018-13053
    Company
    B. Braun Medical Inc
    # of Openings
    1
    Category
    Quality
    Position Type
    Regular Full-Time
    Shift
    8am to 5pm
    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:

    Responsible for establishing standardized and harmonized Change Control and Document Control quality systems for B. Braun Medical Inc., that are compliant, efficient, effective and in alignment with corporate policies, procedures and the best practices in industry.  Ensure change controls activities are properly documented and implemented to avoid gaps and ineffectiveness. Maintain the document control system including managing document change requests, document distribution, archiving. Supervises Change Control and Document Control department staff.

    Responsibilities: Essential Duties

    • Supervises the operation of the organization's Change Control and Document Control systems. Assures department employees compliance and strict adherence to the established procedures and policies. Oversees the performance of functional groups to assure that products and processes meet company and regulatory requirements/standards.  Directs staff to continuously evaluate compliance with regulatory requirements and department efficiency and effectiveness.
    • Responsible for staffing, training, coaching and development of subordinates to maintain and improve product quality and systems consistent with department and company operating objectives.  Select, train, motivate and develop a highly technical staff with expertise in medical devices quality systems to accomplish the department’s objectives, optimize personnel performance and achieve personal and professional growth. Coordinates program communications to employees, assists in the development of training, monitors results, and administers related reward systems.
    • Establishes and maintains comprehensive site Change Control and Document Control systems that are efficient, effective and compliant to applicable cGMP, regulatory requirements and expectations, and the Company’s Quality System policies and procedures.  Work seamlessly with functional business groups to drive continuous improvement in system integration, interfaces with business processes, and efficiencies to ensure effectiveness quality system is maintained.
    • Responsible for incorporating best practices into the Change Control and Document Control systems while maintaining alignment to Company Objectives.  Leads and drives the effort of defining the standard work for consistent and reliable Change Control and Document Control systems execution and, provides direction for process improvement tools for Quality Systems.
    • Partners with Corporate Quality and other B. Braun sites on quality objectives related to quality systems and processes.  Serves as the site Quality project leader and centralized team member for these initiatives.  Ensures that user requirements are properly defined and documented, systems are structured to meet established requirements, and training is effectively executed to all affected personnel prior to implementation. 
    • As part of Quality Systems accountability, supervises the Change Control and Document Control programs to ensure quality records are thorough, comprehensive, well documented and accurate.  Assures root cause investigations and risk assessments are appropriately conducted.  Works with the organization to drive timely completion of changes and corrective and preventive actions in support of the manufacture of the highest quality products and business objects.  
    • Ensure compliance to all regulatory requirements for creation, revision, processing, filing, on-site and off-site storage, retrieval, and disposition of controlled documents at the facility.
    • Maintain the document control system including managing document change requests, document distribution, archiving.
    • Participates in regulatory inspections and customer audits; supervises the support team during inspections and audits to ensure that appropriate documents and information are provided to auditors in a timely manner.
    • Keeps informed of all existing and new regulatory requirements, assures site Quality System continues to comply with changes in regulatory requirements and expectations, and works with other functions to ensure full compliance.
    • Maintains a high degree of personal professional development through a combination internal and external training and participation in professional associations as appropriate.
    • Build and foster strong relationships and partnerships with stakeholders and support groups to meet the demands of a changing business culture and environment.
    • Serves as a key quality systems subject matter expert to the organization.  Participate in organizational training to drive organizational competency in quality system requirements.
    • Performs other related duties as required by management.
    • To keep abreast of changes in the regulations, interpretation of the regulations and revising internal practices and written procedures to comply with the regulatory requirements.

    Expertise: Knowledge & Skills

    • Experience in data analysis, trending and responding to adverse trends in quality system indicators 
    • Experience in performing internal audits and/or supplier audits.
    • Solid understanding of the efficiencies and criticalities of all of the quality systems elements.
    • Ability to use sound scientific judgment and risk management for the facility to prevent regulatory action
    • Ability to proactively identify and anticipate risk of non-compliance in a dynamic environment
    • Ability to make verbal presentations to both small and large groups at a variety of levels both inside and outside of the company.
    • Strict attention to detail required.  Problem detection ability a must. 
    • Demonstrated track record in managing a diverse staff and establishing a clear, strategic direction
    • Leadership in partnering with Operations, R&D, Engineering, Supply Chain, Regulatory and Scientific Affairs, Sales and Marketing, etc.
    • Project Management experience is required, including project initiation, team development, and achieving desired results on time and on budget.

    Qualifications

    Expertise: Qualifications - Experience/Training/Education/Etc

    Required:

    • B.S. in a Scientific discipline
    • 5+ years of developing Quality Systems infrastructure or centralized processes experience in the medical device / pharmaceutical industry
    • 2+ years experience in a quality leadership role required
    • Experience in supporting FDA inspections as quality system subject matter expert and an ability to interpret regulatory requirements.

    Desired:

    • Advanced degree (M.S., M.B.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 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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