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.
Provide overall quality leadership and direction for the B. Braun Medical Inc. Active Device business, which includes design, development, manufacturing, distribution, field training, service, and post market surveillance activities. Lead the development and implementation of the Quality Systems and programs to ensure compliance with company policies and procedures, and industry regulations and standards, including FDA cGMPs, CFRs, ISO 13485:2003, MDD and CMDR. Manage the activities for Quality Assurance, Validation and Quality Control functions to maximize efficiencies of staff, equipment and financial resources to support company goals while ensuring compliance with company quality policies and applicable regulatory requirements. Interface with suppliers, customers and Regulatory Authorities regarding products and quality issues. Ensure compliance and inspection readiness of quality systems with applicable regulatory standards.
Responsibilities: Essential Duties
Responsible for all quality functions within organization.
Develops and implements strategies for ensuring that organizational products and processes meet established quality standards.
Establishes or administers an organizational quality management system and monitors progress against strategic quality-related goals.
Identifies potential quality failures, establishes methods for evaluating quality of raw materials or components, in- progress goods, processes or operations, and oversees development and implementation of corrective actions.
Solicits internal and external feedback with the goal of continuously improving processes or products. --May represent the organization during external inspections or audits.
Responsible for personnel actions including hiring, performance management, termination.
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
Expertise: Knowledge & Skills
Requires breadth of organizational, professional field, and industry knowledge. Ability to integrate critical information from several diverse areas. Champions advanced strategies and concepts.
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 all day-to-day problems.
Contacts are primarily with department supervisors, leads, subordinates, and peers. Frequent contact with external contractors/vendors.
Expertise: Qualifications - Experience/Training/Education/Etc
Bachelor's degree required, Master's degree preferred.
10-12 years related experience required.
Applicable industry/professional certification preferred.
Occasional business travel required
Regular and predictable attendance
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.