Quality Systems Specialist
: Job Details :

Position: Quality Systems Specialist

Location: Zelienople, PA

Duration: 12+ Months Contract

Total Hours/week: 40.00

1st Shift

Client: Medical Device Company

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1B's

Description: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.Key Responsibilities:1. Process service records for Bard/BD Direct and Contract Service Providers (CSP) by reviewing paperwork for accuracy, completeness and correctness.2. 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.3. Review and facilitate weekly report meeting for aged service records with division. Request information or documentation to move records to closure.4. Perform Device History Reviews (DHR) and Process Failure Mode and Effects Analysis (PFMEA) reviews in support of complaint investigations.5. Communicate problems, situations, opportunities, and progress to management.6. Additional task requested, as required.

Educational Qualifications & Previous Experience:• Associate degree in Business Management, Medical Office Admin, or related field• 1 to 3 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

Keywords: quality review, medical device, ServiceMax, TrackWise, Microsoft Office, Word and Excel, DHR, PFMEA,