Quality Systems Specialist II - Computer Systems
Company: B. Braun Medical Inc.
Location: Daytona Beach
Posted on: January 22, 2023
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Job Description:
Overview
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.
Responsibilities
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
Auditing.
* Interfaces with all BBMI sites to ensure core quality systems and
processes are properly implemented and maintained for sustained
compliance.
* 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
expectations.
* 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 & Skills
* 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
action.
* 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
peers.
* 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.
Target Based Range
81900-102400
Qualifications
Expertise: Qualifications -Education/Experience/Training/Etc
Required:
* 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.
.
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:
* 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 Reaching:
* Occasionally:Reaching upward and downward, Push/pull, Stand,
Visual Acuity with or without corrective lenses
* Frequently:Sit
* 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
* 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, Lab
environment, Other
* 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
www.bbraunusa.com. Through its "Sharing Expertise" initiative, B.
Braun promotes best practices for continuous improvement of
healthcare products and services.
Notices
Equal Opportunity Employer Veterans/Disabled
Keywords: B. Braun Medical Inc., Daytona Beach , Quality Systems Specialist II - Computer Systems, Other , Daytona Beach, Florida
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