Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Through close collaboration with its customers, Aesculap provides advanced technologies for general surgery, neurosurgery and closure technologies. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver products and services that improve the quality of patients’ lives.
Experienced Quality professional with, FDA Quality Systems Regulations (21 CFR Part 820), ISO 13485 and ISO 14971 experience. Responsible for ensuring the adequacy of the organizations CAPA system to regulations. Root cause analysis and problem solving expert and trainer. Works with quality management and senior management to ensure CAPAs are adequately resourced and executed in a timely manner. Knowledge and experience with SAP or similar software systems to aid in problem solving and solution implementation. Writes and implements standard operating procedures (SOP) which are necessary to ensure Quality compliance and the safety and performance of Aesculap distributed products. Works closely with other departments including but not limited to Operations, Complaint Handling, Marketing, Supply Chain, and Customer Service to resolve quality related issues.
Responsibilities: Essential Duties
Issues monthly reports to the QC management as requested.
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.
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 Equal Opportunity Employer Minorities /Women/ Veterans/Disabled
Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
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.