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Quality Engineer

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  • ID: 461726
  • Posted: 3/24/2020
  • Location: Tarrytown, NY
  • Category: Pro - Professional
  • Job Type: Temporary
  • Duration: 3 - 6 Months

Description

Acara Solutions is looking for Quality Engineer for our client located Tarrytown, NY.
  • Evaluate safety complaint escalations, make decisions on MDR reporting, and documenting those decisions.
  • File MDRs when needed and communicate (as appropriate) to the Authorized Representative or Regional Unit.
  • Work with members of other teams to review, assess, and close potentially adverse events (pMDRs), including MDR reporting related to IMMULITE systems/ADVIA Chemistry systems/ADVIA Centaur Systems/Automation/ Dimension systems / Dimension Vista systems/Informatics systems.
  • Provide support in all areas associated with MDR/MDVR/MDPR reporting and trending.
  • Provide CPQ support for the above-mentioned systems Product Health Teams.
  • Display of a high level of critical thinking in bringing successful resolution to high-impact, complex, and cross-functional problems is expected.
 
Job Requirements

 
Required Skills / Qualifications:
  • BS degree
  • Minimum of 2 years’ experience with Medical Device Reporting.
Preferred Skills / Qualifications:
  • Good writing, communication and organizational skills necessary.
  • In addition, support the Commercial Product Quality (CPQ) department when working on post market IMMULITE systems/ADVIA Chemistry systems/ADVIA Centaur Systems/Automation/ Dimension systems
  • Dimension Vista systems/Informatics systems related issues from the Escalation Review Council (ERC).
  • Significant knowledge of organization's business practices and issues faced and contributions to problem resolution of those issues.
Additional Information:
  • Upon offer of employment, the individual will be subject to a background check and a drug screen
Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct, and Aleron?s strategic partner, SDI) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.

Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.
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