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.

Responsibilities: Essential Duties

• Establishes 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.

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 needed

Preferred:

• Supervisor/manager experience
• Participated in audits with FDA
• Pharma experience
• Experience with reject/release of materials

Required: Bachelor's degree and 8-10 years of experience

Expertise: Qualifications -Education/Experience/Training/Etc

Required:

• Bachelor's degree required.
• 08-10 years related experience required.
• Regular and predictable attendance
• Ability to work non-standard schedule as needed

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.

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.