Quality Systems Manager
Company: B. Braun Medical
Location: Allentown
Posted on: May 15, 2022
Job Description:
B. Braun Medical, Inc.Quality Systems ManagerUS-PA-AllentownJob
ID: 2021-19674Type: Regular Full-Time# of Openings: 1Category:
QualityAllentown Mfg FacilityOverviewAbout 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 .Responsibilities Position Summary: This
position is responsible for implementing, maintaining, improving
and aligning the Quality Management System (QMS) for the Purchased
Finished Goods and associated business units within the North
America. Specifically; reviewing, revising and maintaining the QMS
procedures to ensure that the work conducted conforms to
established corporate standards and industry regulations/standards.
The position also ensures the local execution of the change
control, document control, learning management, CAPA, NCR and other
Quality Management Systems. Responsibilities: Essential Duties
- Establishes and maintains comprehensive site quality management
systems that are efficient, effective and compliant to applicable
cGMP, regulatory requirements and expectations, and the Company's
Quality System policies and procedures.
- Manages the operation of the organization's Quality System
Group.
- Oversees site supplier audit program activities to ensure
compliance to applicable regulations.
- Collaborates with Corporate Quality and additional company
stakeholders to assure supplier management activities are in
compliance to applicable regulations.
- Maintains and continuously improves B. Braun's Quality
Management System.
- Ensures the internal / external audit programs are running
effectively throughout the organization.
- Plans and executes Customer and/or Third party Audit
- Partners with Corporate Quality to deploy consistent and
compliant processes and procedures across the organization.
- Lead Quality professionals in the monitoring, management and
execution of Change Control (including labeling changes and control
of IFUs on the IFU website).
- Engages in root cause analysis and issue resolution when
inefficiencies or discrepancies occur within the Change Control,
Document Control and Training processes and systems.
- Provides the business unit with consulting support for
accurately processing procedures through the eDMS and
development/maintenance of training assignments in accordance with
corporate procedures.
- Responsible for ensuring the entry of Site Level training
records in the Learning Management System (LMS).
- Responsible for the local process for issuing controlled
documents, reconciliation and record retention in accordance with
internal policies and regulatory requirements.
- Maintains Quality Dashboard metrics for input into Management
Reviews.
- Tracks KPIs and the monitors the performance of the quality
staff, ensuring that the department meets organizational
objectives.The job function listed is not exhaustive and shall also
include any responsibilities as assigned by the Supervisor from
time to time. Expertise: Knowledge & Skills
- 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.
- Provides direct or supervision to a group of employees,
assigning tasks and checking work at frequent intervals.
Accountabilities include work and people scheduling, performance
management and recommendations for hiring decisions.
- 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. QualificationsExpertise: Qualifications
-Education/Experience/Training/Etc Required:
- Bachelor's degree required, Master's degree preferred.
- 06-08 years related experience required.
- Applicable industry/professional certification required.
- Regular and predictable attendance
- Occasional business travel required, Secrecy and invention
agreement and non-compete agreement, Ability to work non-standard
schedule as needed 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,
Visual Acuity with or without corrective lenses
- Frequently:Sit
- Constantly:N/AActivities:
- Occasionally: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/AEnvironmental Conditions:
- Occasionally:Proximity to moving parts, Exposure to toxic or
caustic chemicals (in most areas)
- 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:N/A
- Frequently:Office environment, Production/manufacturing
environment
- Constantly:N/A What We OfferB. 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.NoticesEqual Opportunity Employer Veterans/DisabledAll
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.PI177338870
Keywords: B. Braun Medical, Allentown , Quality Systems Manager, Executive , Allentown, Pennsylvania
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