Quality Systems Specialist

Key Responsibilities

• Process service records for Bard/BD Direct and Contract Service Providers (CSP) by reviewing paperwork for accuracy, completeness and correctness.
• Cook 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.

Educational Qualifications & Previous Experience

• Affiliate degree in Business Management, Medical Office Admin, or related field
• One to three years experience (medical device industry preferred)

Professional Skills & Key Competencies

• 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