QA Engineer

Title: QA Engineer
Duration: 12+ months with possible extension
Location: Andover, MA

This position will be responsible for assisting the Software Supplier Quality team in processing supplier assessment documentation. The ideal candidate will be comfortable communicating with software and cloud based suppliers of all sizes and maturity levels. The candidate will be responsible for verifying supplier files are complete and ready for formal review as well as ensuring information requests and follow-ups are done in a timely manner. Must be adept at applying validation and qualification principles and best practices to a task and delivering quality results. Detailed understanding of QMS structure, software development life cycles, programming standards and cloud based delivery and management required. Candidate should be able to aid in the development of test scripts for software validations. 
Technical Requirements:  
Must have “Expertise” in the following MS applications:  
One Drive  
Must have a professional background in one or more of the following:  
Software development  
Cloud technologies  
Software validation  
Supplier auditing/quality  
Understanding of ISO certifications and SOC reporting standards a Plus+  
Knowledge of FDA regs. a Plus++  
Must be able to identify deficiencies as compared to a standard and close any gaps  
Must be detail oriented, comfortable with reviewing documentation against defined standards  
Professional experience level ? 3 years  
Experience with CAPAs and SCARs a Plus+  

Soft Skills  
Must have excellent communications skills (written and verbal)  
Ability to prioritize tasks to achieve deadlines  
Schedule and lead conference calls  
Must be comfortable following up with suppliers, collecting additional information ensuring timelines are met  
Must have ability to track down sources internal/external for missing or incomplete information  
Develop internal contacts and resources to aid in data gathering and processing of supplier related files  
Must be able to manage multiple workflows and communication strings  
Must be comfortable with managing external influences and competing requests for service while maintaining focus on in process tasks  
Ability to assume ownership of in process work product and driving to closure  
Negotiate and identify resolutions to bring closure to outstanding issues

Please send me your confirmation that no one else has contacted you for this position apart from APN Team.

Thanks and Regards,
Ali Khan
APN Software Services, Inc.
39899 Balentine Drive, Suite 385, Newark, CA 94560 
Direct: 510.870.8798 | Fax: 510.623.5055 |

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