B. Braun

  • Quality Assurance Supervisor

    Job Locations US-PA-Center Valley
    Requisition ID
    2018-12757
    Company
    Aesculap Inc
    # of Openings
    1
    Category
    Quality
    Position Type
    Regular Full-Time
    Shift
    8 a.m. to 5 p.m.
    Site
    Aesculap
  • Overview

    Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Through close collaboration with its customers, Aesculap provides advanced technologies for general surgery, neurosurgery and closure technologies. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver products and services that improve the quality of patients’ lives.

    Responsibilities

    Position Summary:

    Maintains Aesculap, Inc and Aesculap Implant System (AIC/AIS) quality operations in compliance of Good Manufacturing Practices (GMP) and the Good Tissue Practices and in a state of audit readiness. This position is responsible for product safety and quality and has a direct impact on patient safety. All job functions must be carried out responsibly, competently and conscientiously to ensure that AIC/AIS products are safe and effective.

     

    Responsibilities: Essential Duties

     
    • Manage, maintain, and update the AIC/AIS validation master plan ensuring the creation and execution of validation documentation meets FDA regulations.

    • Ensures validation protocols are performed, reported, and approved as necessary to maintain a state of validation for Aesculap processes and equipment and in compliance with the VMP.
    • Acts as the lead and mentor for the Specialists and Technicians within the Quality Department. Coordinates special projects for the Quality Department (Quality Alerts).
    • Coaches new hires on the Change Control Notification, NCR, CAPA, and Deviation systems.
    • Manages the preventive maintenance and calibration programs.
    • SAP Quality Management Super user.
    • Track and monitor effectiveness of document control process and develop/ implement programs designed to increase company employee knowledge of documentation compliance policies.  
    • Works with AIC/AIS departments to provide instruction, advice, and enforcement of GMP/GTP compliance.
    • Provide quality leadership and project management on the creation of electronic systems and workflows to support the QMS (i.e. LIMS, LES, MES, Bdocs, Change Control).  
    • Participates in cross-functional design, development, improvement and investigative activities. Capable of applying and leading teams in the use of Quality Tools, such as FMEA, in design, development, improvement and investigative activities.
    • Reviews and approves SOPs, validations, and other documents and records for accuracy, consistency and compliance with relevant federal and state regulations.
    • Develops technical documents including SOPs, work instructions, software validations, investigations, etc. in compliance to applicable laws and standards.
    • Assists in the development, presentation and recording of training as needed.
    • Prepares materials for and participates in Management Review activities.
    • Oversees the Manufacturing/Prototype Development inspection area.  
    • Must comply with applicable ISO and FDA regulations as stated in AIC Quality Manual.
    • Must embody the Company’s Vision, Mission and Values.
    • Organizes and maintains standards (ISO/ASTM/AAMI, etc) for reference.
    • Organizes and maintains the library of publications and provides notifications of updates.
    • Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws.
    • Responsibilities include interviewing, hiring, and training / development of employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
    • Act as a lead team member in all aspects of GMP quality operations.  
    • Development of and compliance to an annual QA Budget.  
    • Other duties may be assigned.

    Expertise: Knowledge & Skills

    • Requires good working knowledge and experience working with GMP Quality Systems.
    • Must have the ability to process, analyze and present data.
    • Knowledge of basic statistical analysis is required.
    • Computer skills in MS Office; Excel, Word, and Visio.
    • Excellent oral and written communication skills required.
    • Must have strong organizational skills.
    • Must be detail oriented.
    • Experience with electronic systems and workflows to support the QMS (i.e. LIMS, LES, MES, Bdocs, Change Control, Calibration, SAP) is a plus.  
    • Language Skills: Ability to read, analyze, and interpret common scientific and technical journals, regulatory documentation / guidance, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to all levels of the organization.
    • Mathematical Skills: Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
    • Reasoning Ability: Ability to define problems, collect date, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

    Qualifications

    Expertise: Qualifications - Experience/Training/Education/Etc

    Required:

    • B.S./B.A. degree with 7-10 years of Quality System experience in Medical Device, Pharmaceutical or Biotech industry.
    • Thorough knowledge of and ability to interpret the cGMPs and state regulatory requirements is essential.
    • QA Supervisory experience is required.

     Desired:

    • Ability to work extended hours, including evenings and weekends.
    • Excellent interpersonal skills required.
    • Quick learner with good analytical skills.
    • Ability to work independently.
    • Contribute to creating a climate of trust, ethics, and accountability by effectively seeking out and accepting feedback from others.
    • Possess the ability to exceed expectations with the customer in mind and take responsibility for driving key results as well as empower others to achieve desired outcomes.
    • Demonstrate behaviors that drive efficiency by understanding and improving processes as well as sharing best practices.

    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 employee must occasionally lift and/or move up to 30 pounds.

    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. This position could require the handling of instruments that may or may not have been contaminated by blood or other body fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees. The noise level in the work environment is usually moderate.

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