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Manager II , Quality Compliance

Company: B. Braun Medical Inc.
Location: Irvine
Posted on: January 15, 2021

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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