Manager II , Quality Compliance

Company: B. Braun Medical
Location: Irvine
Posted on: January 16, 2021

Job Description:

Are you looking for a challenge within a dynamic global organisation or a German family business? At B. Braun you can find both. For more than 175 years and counting, B. Braun is amongst the world's top healthcare companies operating in 64 countries, with over 60,000 experts networking their knowledge every day. You can thrive in this strong culture of continuous exchange. Become a part of the B. Braun family and share your expertise. Together we improve healthcare.Reference Code US-CAE211-54756About B. BraunB. 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 . Your 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 DutiesAssures 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 AuditPlans 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 & SkillsRequires 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. Your 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. What we offerResponsibilities: 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:N/AFrequently: Stand, SitConstantly: N/AActivities:Occasionally: N/AFrequently: Sitting , Standing, Talking - ordinary, loud/quick, WalkingConstantly: N/AEnvironmental 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: LowOccasionally: Production/manufacturing environment, Warehouse environment, Lab environmentFrequently: N/AConstantly: Office environment Your next step

Keywords: B. Braun Medical, Irvine , Manager II , Quality Compliance, Executive , Irvine, California