Quality Compliance Data Steward II

Company: B. Braun Medical
Location: Irvine
Posted on: June 25, 2022

Job Description:

About B. Braun B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap ® and CAPS ® . Globally, the B. Braun Group of Companies employs more than 61,000 employees in 64 countries. Guided by its Sharing Expertise ® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit . Responsibilities

Position Summary: The Data Integrity Steward has oversight over the site Data Integrity Program. The DI Steward will be responsible for data integrity compliance risk analysis, gap assessments and develops and implements solutions to address gaps. Serve as the Data Integrity SME on data and data management. The Data Steward represents Quality Assurance on projects, including lean initiatives. The Data Steward is responsible for activities that include change controls, non-conformance investigations, procedure revisions, impact assessment reviews and maintaining regulatory compliance. Responsibilities: Essential Duties

• Responsible for the implementation, continuous improvement and project management of the Site Data Integrity Program.
• Maintains comprehensive knowledge of applicable data integrity quality and regulatory requirements and their interpretation.
• Identifies data integrity compliance risks and gaps across the site, communicates those risks to Site Management and develops and implements effective and efficient solutions to address those gaps.
• Coordinates the site's quality, security and maintenance of data therefore ensuring compliant data can effectively support the business process.
• Create data process mapping and risk reduction efforts for data owners and Quality representatives.
• Defines data elements and establishes policies and procedures related to the collection and accuracy of data, and performs tests and audits on data systems.
• Ensures sufficient data quality is maintained so that the data can effective support the business process.
• Provides expertise of data, data management and data to moderately complex aspects of a project.
• Creates methodologies and metrics for tracking performance to required Data Integrity expectations and objectives. The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time. General: It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons. Expertise: Knowledge & Skills
  • Please refer to the Corporate Guidelines or BBMUS Guidelines or job specific authorities where applicable. This list is however not exhaustive and may be amended by the Management from time to time.
  • 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. Frequent contact with external contractors/vendors. Qualifications
    
    Expertise: Qualifications -Education/Experience/Training/Etc Required:
    • Bachelor's degree required.
    • 04-06 years related experience required.
    • Applicable industry/professional certification preferred.
    • Regular and predictable attendance
    • Occasional business travel required, Valid driver's license and passport 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. Additional Information
      
      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, Stand
        • Frequently:Sit
        • Constantly:N/A Activities:
          • Occasionally: Climbing stairs/ladders, Push/pull, Reaching upward and downward, Standing, Walking
          • Frequently:Finger feeling, Hearing - ordinary, fine distinction, loud (hearing protection required), Seeing - depth perception, color vision, field of vision/peripheral, Sitting, Talking - ordinary, loud/quick,
          • Constantly:N/A Environmental Conditions:
            • Occasionally:N/A
            • 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:Low
              • Occasionally:Production/manufacturing environment
              • Frequently:N/A
              • Constantly:Office environment What We Offer B. 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
                
                Through its Sharing Expertise® initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. Notices
                
                Equal Opportunity Employer Veterans/Disabled All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
                
                
                
                PI181272614

Keywords: B. Braun Medical, Irvine , Quality Compliance Data Steward II, Other , Irvine, California