Software Supplier Engineer

  • location: Andover, MA
  • type: Contract
  • salary: $60 - $90 per hour

job description

Software Supplier Engineer

·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 followups 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.

· Technical Requirements:

o Must have "Expertise" in the following MS applications:

§ Word

§ Excel

§ Sharepoint

§ Outlook

§ One Drive

o Must have a professional background in one or more of the following:

§ Software development

§ Cloud technologies

§ Software validation

§Supplier Quality

o Must be able to identify deficiencies as compared to a standard and close any gaps

o Must be detail oriented, comfortable with reviewing documentation against defined standards

o Professional experience level 3 years

o Understanding of ISO certifications and SOC reporting standards a Plus+

o Knowledge of FDA regs. a Plus++

o Experience with CAPAs and SCARs a Plus

Soft Skills

o Must have excellent communications skills (written and verbal)

o Ability to prioritize tasks to achieve deadlines

o Schedule and lead conference calls

o Must be comfortable following up with suppliers, collecting additional information ensuring timelines are met

o Must have ability to track down sources internal/external for missing or incomplete information

o Develop internal contacts and resources to aid in data gathering and processing of supplier related files

o Must be able to manage multiple workflows and communication strings

o Must be comfortable with managing external influences and competing requests for service while maintaining focus on in process tasks

o Ability to assume ownership of in process work product and driving to closure

o Negotiate and identify resolutions to bring closure to outstanding issues

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