BD (Becton, Dickinson and Company) Recall Coordinator in Covington, Georgia
The Recall Coordinator position is located at BD in Covington, GA.
The Recall Coordinator is responsible to ensure the execution of the strategy approved for field actions including product removals, customer notifications and regulatory correspondence. The successful candidate responds to decisions made by management that nonconforming and potentially unsafe products are on the market in order to prevent, eliminate, or reduce the likelihood of harm to the consumer.
Communicate with corporate, the business unit and international regulatory business associates as per company procedures.
Obtains consignee lists and contacts for notifications. Provide primary support to field action activities by executing customer notifications.
Interfaces with sales teams to provide appropriate support to customers.
Ensures mandatory corrections, removals and recalls are managed effectively and
Participates in correction and recall strategies, including effectiveness checks and recall letters and reports.
Lead and implement field action strategies including ensuring global actions are executed and appropriately documented.
Prepare agency reports as related to field actions and circulate for required approvals.
Prepare drafts for regulatory agency progress reports and recall termination requests.
Prepares and submits field safety corrective action notices to the Notified Body.
Perform required tasks to facilitate customer mailings by using internal and third party resources.
Tracks and documents customer responses and recall response rates.
Prepares field action presentations and monthly metrics.
Ensures destruction of returned product either through a third party or by in house destruction activities.
Documents reconciliation of returned product and ensures appropriate approvals are obtained.
Interacts with Field Assurance, Quality Systems, Marketing/Sales, International Business Centers, Customer Service, Supply Chain, Regulatory Affairs, and Management.
Perform other duties as assigned
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Proficient in the use of a personal computer with intermediate in Microsoft Word, Excel, PowerPoint and Access.
Detailed oriented and strong organizational skills.
Strong communication and customer service skills.
Ability to multitask efficiently.
Ability to be flexible in a fast paced environment.
Ability to work independently with minimal supervision.
Ability to apply common sense understanding to carry out instructions furnished in oral, written or diagram form.
Ability to solve practical job-related problems, or recognize the need to ask supervision for assistance.
BS/BA degree required.
Minimum two years of experience with FDA regulated industry.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to use hands to finger, handle or feel. The employee is occasionally required to stand and reach with hands and arms and lifts and/or moves up to ten pounds. Employee is required to meet with other personnel in other areas of building. Specific vision abilities required by this job include close vision.
This position works in an office and warehouse environment. The noise level in the work environment is moderate. Must be trained in blood-borne pathogens and handling bio-hazardous materials.
Industry Standard/Category: Field Assurance Specialist/Quality
Career Level: experienced
Division Name: Bard Medical
External Company Name: C.R. Bard, Inc.
External Company URL: www.crbard.com
Street: 8195 Industrial Blvd.
C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.
Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.