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This position is responsible for owning the quality review of domestic and international service records by identifying conflicts, dependencies and risk of release to ensure Quality Assurance Standards and procedures are met.
Job Responsibility:
Process service records for Bard/BD Direct and Contract Service Providers (CSP) by reviewing paperwork for accuracy, completeness and correctness
Coordinate with Field Assurance (FA) in following up with service providers to clarify issues with complaint records so that the records can be closed in a timely manner in accordance with divisional target dates and regulatory requirements
Review and facilitate weekly report meeting for aged service records with division. Request information or documentation to move records to closure
Perform Device History Reviews (DHR) and Process Failure Mode and Effects Analysis (PFMEA) reviews in support of complaint investigations
Communicate problems, situations, opportunities, and progress to management
Additional task requested, as required
Requirements:
1 to 3 years experience (medical device industry preferred)
Familiarity with service management systems ServiceMax or TrackWise
Proficient skills in Microsoft Office, including Microsoft Word and Excel
Excellent organizational skills and attention to detail
The ability to build relationships within the organization
Ability to multi-task and adapt to changes quickly
Associate degree in Business Management, Medical Office Admin, or related field