B. Braun

  • QA Validation Spec III

    Job Locations US-FL-Daytona Beach
    Requisition ID
    2019-14019
    Company
    B. Braun Medical Inc
    # of Openings
    1
    Category
    Quality
    Position Type
    Regular Full-Time
    Shift
    8am - 5pm, depending on business needs
    Site
    Daytona Beach, FL
  • 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:

     

    The QA Validation Specialist III will work with the QA Validation team. In this position the individual will be responsible for supporting Engineering and Quality for new equipment, software or processes or modifications to existing equipment, software or processes on site. 

     

    Responsibilities: Essential Duties

    • Executes qualification and validation in compliance to regulatory requirements by/with/as carry out qualification and validation according to the Validation Program.
    • Use test equipment, instruments and methods to produce data for engineering studies and validations.
    • Perform data analysis using statistical methods as appropriate to produce conclusions and recommendations for relevant work activities.
    • Preparation and maintenance of qualifications and validations documentation.
    • Handling/maintenance/calibration measuring devices used for validation for its compliance.
    • Document root cause and corrective/preventive actions of gap found during validation activities.
    • Support Pharma/Med Device Engineering projects.
    • In process/equipment in production trial/test run for machines/process to establish process parameter.
    • Process/quality improvement.
    • Support Management/Superior in qualification and validation activities.
    • When necessary, provide validation documentation for change control evidence.

    The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

     

    Expertise: Knowledge & Skills

    • Requires advanced knowledge of professional field and industry. Influences the development of and drives the application of principles, theories, concepts. Determines best course of action.
    • Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training , assigning and checking the work of lower level employees. Referring only complex problems and issues
    • Judgement is required in resolving complex problems based on experience.
    • Contacts are primarily with department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors.

    Qualifications

    Expertise: Qualifications - Experience/Training/Education

     

    Required:

    • Bachelor's degree required, Master's degree preferred
    • 04-06 years related experience required.
    • Occasional business travel required, Ability to work non-stand schedule as needed

    Preferred:

    • Applicable industry/professional certification preferred.

     

    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 expected to:

     

    • Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.

    Lifting, Carrying, Pushing, Pulling and Reaching:

    • Occasionally:   Reaching upward and downward, Push/pull
    • Frequently:   Stand
    • Constantly:   Sit

    Activities:

    • Occasionally:   Finger feeling, Hearing - ordinary, fine distinction, loud (hearing protection required), Push/pull, Reaching upward and downward, Stooping/squatting
    • Frequently:   Standing
    • Constantly:   Sitting

    Environmental Conditions:

    • Occasionally:   Proximity to moving parts
    • Frequently:   N/A
    • Constantly:   N/A

    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.

    • Noise Intensity:  Moderate
    • Occasionally:     Production/manufacturing environment
    • Frequently:     N/A
    • Constantly:    Office environment

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed

    Need help finding the right job?

    We can recommend jobs specifically for you! Click here to get started.