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.
Responsible for implementing, maintaining and improving the Quality Vigilance System for all Aesculap US sites. Specifically, interactions with the Food and Drug administration with regards to corrections and removals. He/She will be instrumental in contributing to defining the direction and plans for recalls and ensuring the site is 21 CFR 806 complaint. Will lead recalls, Corrections and Removals. Also he/she will work directly with the Vigilance group to monitor possible recall needs.
Must be comfortable exercising latitude in ensuring the site is compliant with the Aesculap Quality System, the FDA quality regulations and standards it is built on. Comfortable coaching all employees on the Aesculap Correction and Removal process and working professionally with others to reach understanding and agreements as necessary. Represents the company as a primary FDA Recall contact, comfortable communicating internally and externally as well as collaborating at various levels. This individual must be comfortable working autonomously in that much of their work will be completed with limited oversight.
Responsibilities: Essential Duties
Secondary or peripheral job functions:
Expertise: Knowledge & Skills
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 30 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.
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.