Mgr III QA Quality Systems
Company: B. Braun Medical
Location: Irvine
Posted on: May 13, 2022
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Job Description:
B. Braun Medical, Inc.Mgr III QA Quality SystemsUS-CA-IrvineJob
ID: 2021-17548Type: Regular Full-Time# of Openings: 1Category:
QualityIrvine 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 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
www.BBraunUSA.com.ResponsibilitiesManage the development,
establishment, and maintenance of Quality systems, policies,
processes, procedures and controls ensuring that performance and
quality of cGMP documentation and records conforms to established
standards. This position will manage the Change Control, CAPA,
Documentation Control, Quality Management Review processes. The
Quality Systems Manager will be responsible for continuous
improvement of the Quality Systems in response to business needs,
customer audits and regulatory inspections and overall oversight of
the systems. Responsibilities: Essential DutiesManages programs and
activities within the quality assurance functions of an
organization. Administers policies and programs ensuring that
organizational products and processes meet established quality
standards. Participates in the development, implementation and
administration of an organizational quality management system and
monitors progress against strategic quality related goals. Manages
the work of a team of analysts that collect data identifying
potential quality failures, evaluate quality of raw materials or
components, in progress goods, processes or operations, and
implement and measure the impact of corrective actions. Solicits
internal and external feedback with the goal of continuously
improving processes or products.Manage the Quality Systems group to
ensure that systems and processes are operation in a state of
control and in compliance with regulatory requirement and internal
SOPs.Support and drive the ongoing implementation of Quality
Management SystemsManage the document control function, including
issuance and archival of GMP documentation, issuance of production
records. Review and approve corrective and preventive (CAPA)
actions and ensure documents are closed in a timely manner. Manage
the CAPA system, ensuring appropriate CAPA are identified and
implemented as required.Manage the SOP system to ensure that
procedures are current and reflect the intended process.Administer
the Change Control program to ensure all changes are appropriately
assessed, documented, implemented and closed on time. Develop and
track key Quality metrics and KPIs to monitor the performance of
the Quality System; perform trend analysisAssist the Head of QA
with all customer, third-party and regulatory audits including
preparation of responses to audit and inspectional observations.
Responsible for personnel actions including hiring, performance
management, termination 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 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.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 experience.Contacts are primarily with department supervisors,
leads, subordinates, and peers. Frequent contact with external
contractors/vendors. QualificationsExpertise: Qualifications -
Experience/Training/Education/Etc Required:Bachelor's degree
required, Master's degree preferred10-12 years related
experience.Occasional business travel.Regular and predictable
attendance.Desired:Applicable industry/professional certification
preferred.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: 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
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/pullFrequently: Stand, Sit, Visual Acuity
with or without corrective lensesConstantly:
N/AActivities:Occasionally: Climbing stairs/ladders, Push/pull,
Reaching upward and downwardFrequently: Sitting , Standing, Talking
- ordinary, loud/quick, WalkingConstantly: Hearing - ordinary, fine
distinction, loud (hearing protection required), Seeing - depth
perception, color vision, field of vision/peripheralEnvironmental
Conditions:Occasionally: N/AFrequently: N/AConstantly: N/AWork
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: ModerateOccasionally:
Production/manufacturing environment, Warehouse
environmentFrequently: Office environment, Lab
environmentConstantly: N/AWhat 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.PI177359883
Keywords: B. Braun Medical, Irvine , Mgr III QA Quality Systems, Other , Irvine, California
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