Quality Systems Manager

Company: B. Braun
Location: Daytona Beach
Posted on: May 3, 2021

Job Description:

About 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.Position Summary:Responsibilities: Essential DutiesEstablishes and maintains comprehensive site quality management systems that are efficient, effective compliant to applicable cGMP, regulatory requirements and expectations, and the Company’s Quality System and policies and procedures.Manages the operation of the organization's Quality System Group.Oversees site supplier audit program activities to ensure compliance to applicable regulations.Collaborates with Corporate Quality and additional company stakeholders to assure supplier management activities are in compliance to applicable regulations. Ensures the internal / external audit programs are running effectively throughout the organization.Plans and executes Customer and/or Third-party Audit.Directly manage Quality Systems professionals responsible for change control, compliance, audits and investigations.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.Judgement is required in resolving all day-to-day problems.Manages entry to intermediate level employees of a department or a function with 1 or 2 sections. Ensures budgets, schedules, and performance requirements are met.Ability to work non-standard schedule as neededPreferred:Supervisor/manager experienceParticipated in audits with FDAPharma experienceExperience with reject/release of materialsRequired: Bachelor's degree and 8-10 years of experienceExpertise: Qualifications -Education/Experience/Training/EtcRequired:Bachelor's degree required.08-10 years related experience required.Regular and predictable attendanceAbility to work non-standard schedule as neededWhile 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.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 duties 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: StandConstantly: SitActivities:Occasionally: N/AFrequently: StandingConstantly: SittingEnvironmental Conditions:Occasionally: N/AFrequently: Proximity to moving partsConstantly: 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: LowOccasionally: N/AFrequently: N/AConstantly: Office environment, Lab environmentEqual Opportunity Employer Veterans/Disabled

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