Manager II , Quality Compliance
Company: B. Braun Medical Inc.
Location: Irvine
Posted on: January 15, 2021
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Job Description:
Manager II , Quality ComplianceUS-CA-IrvineJob ID:
2020-17472Type: 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.ResponsibilitiesPosition Summary:Provide quality
audit and regulatory compliance expertise for pharmaceutical
manufacturing and quality processes and related products within
Irvine Operations. Ensure internal site compliance to applicable
regulations, standards and quality systems and through direct
interactions across all functional lines and periodic auditing.
Establish guidelines and requirements for quality and regulatory
compliance in supporting special projects and ongoing
operations.Responsibilities: Essential Duties* Assures quality
systems are in compliance to national and international guidelines,
standards and regulations.* Maintains and continuously improves B.
Braun's Quality Management System.* 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 yearly basis.* 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 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/EtcRequired:* Bachelor's degree
required, Master's degree preferred.* 08-10 years related
experience required.* Applicable industry/professional
certification preferred.* Occasional business travel required,
Valid driver's license and passport.* 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.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.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
status.PI127541089
Keywords: B. Braun Medical Inc., Irvine , Manager II , Quality Compliance, Executive , Irvine, California
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