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 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.
Direct the site Quality Assurance (QA) organization and manage staff of QA professionals. Assure effective execution of the site quality management system and provide Quality Assurance expertise, oversight and support for manufacturing, investigations of quality events, quality data trending and analysis, CAPA, audit management, risk management, field action management, and change control. Site Subject Matter Expert on Quality Assurance, Quality Systems and Quality Compliance best practices and technologies for pharmaceutical manufacturing and provide technical and tactical support for the site to ensure compliance with regulatory requirements and expectations. Interact with FDA and other regulatory authorities as Subject Matter Expert for site Quality Assurance processes and procedures. Manage the development and implementation of related programs to maximize efficiencies of staff and budgetary resources necessary to support the company goals while assuring compliance with regulatory requirements. Operate in accordance with company policies and procedures, FDA Regulations, ISO Standards, EU and Canadian Regulations, where applicable.
Responsibilities: Essential Duties
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
Expertise: Qualifications - Experience/Training/Education/Etc
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.
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.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions 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:
Lifting, Carrying, Pushing, Pulling and Reaching:
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.
Equal Opportunity Employer Veterans/Disabled