B. Braun

  • Supv III QC Process Control

    Job Locations US-CA-Irvine
    Requisition ID
    2018-12626
    Company
    B. Braun Medical Inc
    # of Openings
    1
    Category
    Quality
    Position Type
    Regular Full-Time
    Shift
    9:00am- 8:00pm
    Site
    Irvine, CA
  • 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 supervising QC Associates responsible for performing physical testing, label control, control and disposition of materials, process verifications, environmental monitoring sampling, quality investigations and resolution, batch record review. Ensures that personnel operate efficiently and effectively while performing routine and non-routine tasks.

     

    Together with the Manufacturing, Technical Services and Quality Engineering teams, the incumbent of this position will be accountable for the performance of their assigned operational area against key business objectives such as safety, quality, compliance, and production costs/output. The incumbent will collaborate with peers to manage performance of equipment, systems, and processes; and will work to improve the output, efficiency or quality of the associated manufactured products.

      

    Responsibilities: Essential Duties

     

    • Supervises QC Associates responsible for performing physical testing, label control, control and disposition of materials, process verifications, environmental monitoring sampling, investigations, and batch record review in compliance with cGMP and with established policies and procedures.
    • Schedules and coordinates a wide variety of testing and monitoring activities to assure timely execution, in accordance with established business results.
    • Performs associated supervisory duties, including annual performance reviews.
    • Performs final review of test data, reports to ensure conformance to the established specifications and other related standard operating procedures.
    • Responsible for review of completed Production Records prior to release to Quality Assurance.
    • Investigates discrepancies and customer complaints to determine the impact on the product quality, the root cause and corrective actions to preclude further deviations of a similar nature. Create standard work and implement process improvement to reduce the incidence of product impacting discrepancies and/or minimize delays associated with discrepancy containment, investigation and immediate corrections.    
    • Evaluates complaint samples received from customers to support effective investigation. Level of support required is based upon product, technical and functional expertise. Responsible for performing/supporting quality investigations in a timely and thorough manner per applicable investigation procedures.
    • Responsible for identifying and resolving in-process deviations and product non-conformances.
    • Drives, participates in and monitor effectivity, in a timely and thorough manner, including the Material Review Board’s actions to include product impact assessment, product correction, investigation, root cause analysis, identification and implementation of corrective and preventive actions as applicable. Builds and sustains a problem solving culture through coaching, mentoring, facilitating with tools such as Fishbone Diagram, 5 Whys, Contradiction Matrix and others as necessary.
    • Responsible for revising QC functional procedures to assure that they remain current and incorporate best practices, as part of continuous improvement.
    • Assists with the annual department budget. Monitor business performance through the use of leading Key Performance Indicators and supporting data trending. Take action to investigate and correct as trends shift.
    • Identifies opportunities to improve manufacturing or business processes. Implements actions that reduce waste, scrap and time, etc., resulting in lower cost of goods sold.
    • Responsible for recruiting and training QC Associates, coach and mentor direct reports and peers to instill a quality mindset by strictly following procedures, reporting issues and escalating as necessary to ensure compliance.
    • Ensures individual training is completed on time for self and direct reports. Review and revise curricula as job requirements change. Identify ongoing job specific and/or technical training needs to sustain competencies and knowledge to cGMPs.
    • Demonstrates and encourages a culture of quality by stopping processes and correcting them when an issue is observed or reported with potential to impact safety, quality and/or compliance.
    • Actively model, coach and engage employees to ensure safe conditions (ergonomics) and actions (behaviors) in all applicable functional work areas. Proactively correct identified hazards to prevent incidents and injury, including driving and participating in red dot walks or risk assessments.
    • Other duties as assigned.

    Expertise: Knowledge & Skills

     

    • Computer knowledge.
    • Theoretical knowledge of subject matter, CGMP, FDA guidelines, GLP and USP’s.
    • Ability to work effectively in a multi-cultural environment.
    • High energy, people oriented individual with the ability to develop and to motivate subordinates.
    • Good organizational skills with the ability to promote and adapt to changes.
    • Excellent verbal and written communication skills are required.
    • Must be able to operate independently, analyze information, and make quality decisions under pressure.

    Qualifications

    Expertise: Qualifications - Experience/Training/Education/Etc

     

    Required:

     

    • BA/BS degree in related science.
    • 5 or more years of previous supervisory experience.
    • At least 8 years Quality Control experience.
    • Familiarity with the methods of statistical process control and experience in the design and implementation of sampling plans.

    Desired:

    • N/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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