New

Quality Compliance Audit Manager

B Braun Medical
tuition reimbursement, 401(k)
United States, Pennsylvania, Allentown
Feb 26, 2026
Job Description You're an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That's why we would like to keep developing our company with you. Keeping your future in mind, we're making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise. Quality Compliance Audit Manager Company: B. BRAUN MEDICAL (US) INC Job Posting Location: Allentown, Pennsylvania, United States Functional Area: Quality Working Model: Remote Days of Work: Wednesday, Tuesday, Thursday, Friday, Monday Shift: 5X8 Relocation Available: No Requisition ID: 9719 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 64,000 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 Duties Conduct and document gap analysis to new/revised regulations and provide leadership and project management for implementation, asrequired Maintains and continuously improves B. Braun's Quality Management System. Collaborate with sites toestablishinternal audit schedules andmonitorschedule adherence. Monitor site quality system certificateexpirationand work with the notified body to ensure resolution prior to certificateexpiration Coach, mentor and train site personnel on theinternal andsupplier audit program, associatedformsand industry best practice. Prepare training materials for different regulations and quality systems to ensure compliance requirements are understood at all levels of the organization. Serve as quality and regulatory compliance subject matter expert for training execution. Perform supplier and internal quality system audits includingexecutingand preparingauditreportona timelybasis. Maintains comprehensive knowledge of applicable quality and regulatory requirements (FDA, ISO, MDSAP, JQMS, CDMR, etc.) and their interpretation. Keeps informed of all existing and new regulatory requirements to provide regulatory complianceexpertiseto the company by sharing external regulatory and industry trends. Provide support,expertise, and direction to sites during regulatory audits and inspections. Develop strategies to ensure successful audit preparation,executionand inspection outcomes. Work with sitesto prepare responses to regulatory audit observations. The job function listed is not exhaustive and shall also include anyresponsibilities asassigned 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. Determinesbestcourse of action. Work under minimal supervision. Relies on experience and judgement to plan andaccomplishassigned goals. May periodicallyassistin orienting, training, and/or reviewing the work of peers. Judgement isrequiredin resolving complex problems based on experience. Contacts are primarily with department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors. Expertise: Qualifications -Education/Experience/Training/Etc Required: Bachelor's degreerequired,Master'sdegree preferred. 10-12 years related experiencerequired. Applicable industry/professional certificationrequired. Regular and predictable attendance Frequent business travelrequired While performing the duties of this job, the employeeis regularly required tosit and talk or hear. The employeefrequentlyis required touse hands to handle or feel andreach withhands and arms. The employeeis occasionally required tostand and walk. The employee must occasionally lift and/or move up to 20 pounds. 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 abilityrequired. Management reserves the right to add, modify,changeor rescind the work assignments ofdifferent positionsdue to reasonable accommodation or other reasons. Physical Demands: While performing the duties of this job, the employee is expected to: Light work - Exerting up to 20lbsof force occasionally, and/or up to 10 pounds of forcefrequently, and/or a negligible amount of force constantlyto moveobjects. Lifting, Carrying, Pushing, Pulling and Reaching: Occasionally:Reachingupward and downward, Push/pull, Stand Frequently:Sit Constantly:N/A Activities: Occasionally:Climbingstairs/ladders, Push/pull,Reachingupward and downward, Standing, Walking Frequently:Fingerfeeling, Hearing - ordinary, fine distinction, loud (hearing protection required), Seeing - depth perception, color vision, field of vision/peripheral,Sitting ,Talking - ordinary, loud/quick Constantly:N/A Salary Range: $140k - $165k #IND123 The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate. 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. We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here. Apply now