B. Braun Medical, Inc.
Company: B. BRAUN MEDICAL (US) INC
Job Posting Location: Allentown, Pennsylvania, United States
Functional Area: Quality
Working Model: Hybrid
Days of Work: Friday, Thursday, Wednesday, Tuesday, Monday
Shift: 5X8
Relocation Available: No
Requisition ID: 10833

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

• Provide strategic leadership for all franchise Quality Assurance functions to ensure compliance with global medical device regulations, including 21 CFR 820, ISO 13485, EU MDR, CMDR, CFDA, and PMDA.
• Ensure medical devices are designed, validated, manufactured, and distributed in accordance with Design Control requirements, risk management principles (ISO 14971), and BBMI quality standards.
• Partner with Business Unit leadership to integrate quality and regulatory expectations into product development, manufacturing operations, and lifecycle management.
• Represent Corporate Quality in franchise leadership forums, design reviews, manufacturing site assessments, and crossfunctional project teams for device programs.
• Develop, maintain, and report medical device–specific quality metrics (e.g., NC/CAPA trends, complaint rates, audit findings, field actions) to drive continuous improvement across the QMS.
• Provide executivelevel reporting on device quality performance, compliance risks, manufacturing site status, and key project milestones.
• Coordinate FDArequired and global postmarket surveillance activities, including complaint handling, vigilance reporting, trend analysis, and field corrective actions, in partnership with Corporate PMS.
• Champion a strong medical device quality culture and support harmonization of a unified corporate QMS across all device operations and manufacturing sites.
• Develop and manage the franchise quality budget, including staffing, operational expenses, supplier quality oversight, and special compliance or remediation projects.
• Serve as the primary liaison with regulatory authorities during medical device inspections, audits, and communications related to product quality, compliance issues, and site performance.
• Partner closely with Regulatory Affairs, Engineering, and R&D to ensure that process development, and manufacturing adhere to quality standards.

Expertise: Knowledge & Skills

• Requires breadth of professional field and industry knowledge. Ability to integrate critical information and champion advanced strategies/concepts through the organization. Drives development of advanced technologies, principles and processes.
• Directs the activities of broad functional area through division heads who are responsible for planning, budgeting, costs, methods and employees. Determines actual organizational structure and allocation of resources.
• Judgement is required in resolving complex problems based on experience.
• Represents the organization as a prime contact on projects and departmental operations. Interacts with senior internal and external personnel on issues often requiring coordination across organizational lines.

Expertise: Qualifications -Education/Experience/Training/Etc

Required:

• Bachelor's degree required, Master's degree preferred.
• Minimum of 10 years related experience required, with at least 7 years of quality management experience required.
• Applicable industry/professional certification preferred.
• Occasional business travel required

While 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.

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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.

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.