B. Braun

  • Manager, QC Process Control

    Job Locations US-PA-Allentown
    Requisition ID
    2018-12921
    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:

     

    Manage, plan, organize and direct the activities related to Quality Control to ensure timely completion of the functional tasks.  Manage the development and implementation of related programs to maximize efficiencies and effectiveness of the function and budgetary resources necessary to support the company goal while complying with regulatory requirements.  Operate in accordance with company policies and procedures, FDA Regulations, ISO Standards and Canadian Medical Device Regulations, where applicable. 

     

    Responsibilities: Essential Duties

    • Oversees the performance of functional groups to assure that raw materials, subassemblies, finished products, purchased products and processes meet company and regulatory requirements/standards.
    • Support validation and technology transfer from engineering to productions.
    • Responsible for staffing, training, coaching and development of subordinates to maintain and improve product quality and systems consistent with department and company operating objectives. Responsible for the motivation and development of subordinates to optimize their performance and personal and professional growth.  Coordinates program communications to employees, assists in the development of training, monitors results, and administers related reward systems.
    • Provide technical assistance and direction to the other functional groups. Effectively interact and communicate with manufacturing, engineering, regulatory and quality to ensure all necessary QC tests are performed and timely resolution to product quality issues is obtained. 
    • Interface with regulatory agencies in conjunction with new device submissions and during routine audits, field complaint investigations and technical interchanges to present the company viewpoint.
    • Oversee and/or direct the investigation of excursions in Manufacturing or other related operations resulting in abnormal operation rejections. Resolves nature of cause, impact, disposition and corrective actions.
    • Maintain oversight of manufacturing activities for quality compliance. Take immediate action to resolve issues and escalate to upper management as necessary.  Review and approve product, process, and material related nonconformance for technical accuracy, completeness, and justifications supporting recommended actions to be taken.
    • Ensure the release of products manufactured by B. Braun within established timeframes required to meet company operating objectives.
    • Monitors the quality of products and implements systems and strategies to ensure product quality to established governmental regulations and company specifications. Ensure effectiveness of Material Review Boards.  Coordinates the reporting of quality issues to management.
    • Ensure personal training in accordance with department training matrix.
    • Develop and maintain department budget and financial resources in excess of $500,000.
    • Performs other related duties as required by management.

    Expertise: Knowledge & Skills

    • Broad knowledge of quality policies and thorough understanding of FDA Regulations and ISO Standards for medical device or pharmaceutical operations.
    • Must be knowledgeable with CAPA, document control, product release, risk management, validation, design controls, and process development.
    • Strong knowledge in statistical process control and ability to apply advanced statistical techniques.
    • Must have experience interfacing with FDA and ability to effectively write audit responses, conduct root cause analysis, and document investigations.
    • Must be able to work with all phases of company manufacturing and quality operations.
    • Excellent written and verbal communication and interpersonal skills
    • Must be able to effectively manage multiple priorities and projects
    • Proficient in the use of computers including a wide variety of word processing and spreadsheet software packages
    • Sufficient human relations skills to effectively staff and manage relevant personnel and functions to assure that company goals and responsibilities are met.
    • Ability to make verbal presentations to both small and large groups at a variety of levels both inside and outside of the company.

     

    Qualifications

    Expertise: Qualifications - Experience/Training/Education/Etc

     

    Required:

    • 6-8 years professional experience with at least 2 years of supervisor/manager experience.
    • Bachelor's Degree required
    • Minimum 5 years experience in quality systems documentation & administering FDA and ISO requirements.
    • Travel to any B. Braun facility domestic and international.

    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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