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
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