Quality Complianc Auditing Spc
Company: B. Braun Medical, Inc.
Posted on: May 15, 2022
B. Braun Medical, Inc.Quality Complianc Auditing
SpcUS-PA-Allentown - US-PA-AllentownJob ID: 2021-19328Type: Regular
Full-Time# of Openings: 2Category: 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
.ResponsibilitiesPosition Summary: Responsible for delivering audit
services to support Quality Operations in accordance with all BBMI
process and procedures, regulatory requirements to assure timely,
effective audit service and delivery that assures satisfaction of
our customer regulatory compliance needs and requirements. Able to
manage, deliver and implement new initiatives for emerging business
and regulatory standards impact to BBMI business value chains. The
ideal candidate must have working knowledge of with cGxPs as well
as ISO, ICH and USPs and applicable regulations. Responsibilities:
- Assures quality systems are in compliance to national and
international guidelines, standards and regulations.
- Maintains and continuously improves B. Braun's Quality
- Establishes new or improves existing infrastructure to achieve
conformance to the ISO 13485, ISO 9001 requirements, the cGMP QS
Regulation as well as FDA's new auditing techniques.
- Follows-up on all Corrective and Preventive Action (CAPA) and
to make sure that the datelines will be met.
- Plans and executes Customer and/or Third Party Audit
- Plans and executes the whole internal quality audit (IQA)
activities from start to end.
- Prepares Auditor History Log and Qualified Auditors List on
- Follows-up on audit findings for internal and external audits
and regular update of IQA database.
- Coordinates and maintains the Supplier Audit Process together
with Supply Chain Management (SCM).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
- Manages activities of a functional area which has at least 2
departments or major functions through managers and/or experienced
employees. Responsible for cost, method, and employee results.
- Judgement is required in resolving complex problems based on
- Interacts with internal and/or external clients and customers
to negotiate and interpret information on projects and unit
operations. May consult with senior
management.QualificationsExpertise: Qualifications -
- Bachelor's degree required, Master's degree preferred.
- 08-10 years related experience required.
- Applicable industry/professional certification required.
- Frequent business travel required, Valid driver's license and
passport, Secrecy and invention agreement and non- compete
agreement, Ability to work non-standard schedule as needed.
- Regular and predictable attendance.Desired:
- N/AWhile 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: The
physical demands described here are representative of those that
must be met by an employee to successfully perform the essential
functions of this job. Reasonable accommodations may be made to
enable individuals with disabilities to perform the essential
functions. While performing the duties of this job, the employee is
- 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: 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/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: Low
- Occasionally: N/A
- Frequently: N/A
- Constantly: Office environmentWhat 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
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.PI177338855
Keywords: B. Braun Medical, Inc., Allentown , Quality Complianc Auditing Spc, Other , Allentown, Pennsylvania
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