Quality Systems Specialist II - Computer Systems
Company: B. Braun Medical Inc
Posted on: September 23, 2022
B. Braun Medical, Inc.
Quality Systems Specialist II - Computer Systems
Job ID: 2022-21069
# of Openings: 1
Corp at Allentown Auxiliary
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 64,000 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 www.BBraunUSA.com.
Position Summary: Responsibilities: Essential Duties
- Establishes guidelines for computer system validation and
oversees the computer and controls validation program for B. Braun
U.S. to ensure compliance with FDA requirements.
- Responsible for establishing standardized and harmonized core
quality systems and processes for B. Braun Medical Inc. (BBMI) that
are compliant, efficient and effective and employ best practices in
industry. Focus will be on core computer systems such as SAP C3,
QM, CAPA/Complaints/Deviations/Discrepancies, LabWare, LIMS,
Laboratory Instruments, Management of Change, Validation, and
- Interfaces with all BBMI sites to ensure core quality systems
and processes are properly implemented and maintained for sustained
- Ensures quality and regulatory compliance requirements are
identified, documented, integrated, and maintained to avoid gaps
and ineffectiveness. Supports Data Integrity (DI) lab remediation
activities for all sites.
- Supervises and otherwise manages personnel and contractors
involved in computer and control system validation.
- Provides technical guidance and supervision to B. Braun U.S.
computer system validation engineers and Global Operations at
multiple B. Braun U.S. facilities.
- Implements and maintains the Corporate Operating Procedures and
centralized processes and templates, identifies and implements
process improvement tools for Quality Systems to ensure the process
requirements of Quality Compliance systems integrated.
- Understands the efficiencies and criticalities of all of the
quality systems elements at BBMI. Works seamlessly with functional
business groups to improve upon vertical and horizontal system
interfaces and efficiencies.
- Executes the strategic direction for Quality Systems Excellence
Programs & Deployment Management. Understands quality and
regulatory requirements and integrates these within the company's
Quality Management System in accordance with system capabilities.
Evaluates and implements system and process improvements to ensure
that quality systems continue to meet regulatory requirements and
- Reviews regulatory rules and guidelines pertaining to computer
systems and electronic data and determine their impact on B. Braun
U.S. operations. Stays current with FDA requirements for these
rules. The job function listed is not exhaustive and shall also
include any responsibilities as assigned b" Expertise: Knowledge &
- Requires full working knowledge of relevant business practices
and procedures in professional field. Uses standard theories,
principles and concepts and integrates them to propose a course of
- Work under minimal supervision. Relies on experience and
judgement to plan and accomplish assigned goals. May periodically
assist in orienting, training, and/or reviewing the work of
- Judgement is required in resolving complex problems based on
- Contacts are primarily with department supervisors, leads,
subordinates, and peers. Occasional contact with external
Expertise: Qualifications -Education/Experience/Training/Etc
- Bachelor's degree required.
- 06-08 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. .
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:
- Moderate work - Exerting up to 40 lbs of force occasionally,
and/or up to 20 lbs of force frequently, and/or 10 lbs force
constantly to move objects. Lifting, Carrying, Pushing, Pulling and
- Occasionally:Reaching upward and downward, Push/pull, Stand,
Visual Acuity with or without corrective lenses
- Constantly:N/A Activities:
- Occasionally:Finger feeling, Push/pull, Reaching upward and
downward, Seeing - depth perception, color vision, field of
vision/peripheral, Standing, Walking
- Frequently:Hearing - ordinary, fine distinction, loud (hearing
protection required), Sitting , Talking - ordinary, loud/quick
- Constantly:N/A Environmental Conditions:
- Occasionally:Proximity to moving parts
- 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, Lab
- Frequently:Office environment
- Constantly:N/A 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
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
Keywords: B. Braun Medical Inc, Allentown , Quality Systems Specialist II - Computer Systems, Other , Allentown, Pennsylvania
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