Entry level Quality Engineer (medical device, onsite , any visa ok)- AK job vacancy in Cube Hub Inc – Jobs in New York

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Job Details
Company Name : Cube Hub Inc
Company Location : Tarrytown, NY 10591
Job Position : Entry level Quality Engineer (medical device, onsite , any visa ok)- AK
Job Category : Jobs in New York

Job Description :

Job Title: Quality Engineer 1

Location: Tarrytown NY

Duration: 6-12 months contract

Shift Details: 8:00 AM – 4:30 PM

candidates to be fully vaccinated or obtain approval of special medical or religious exemption within three days of worker start date.

Job Description:

  • 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.
  • 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).
  • 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/or cross-functional problems is expected.
  • Demonstrate a significant knowledge of organization’s business practices and issues faced and contributions to problem resolution of those issues.

Requirements:

  • 2-3 years of experience with complaint handling and Medical Device Reporting (US and Outside of the US).
  • Good writing, communication and organizational skills necessary.
  • Education: BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas.

#IND2

Job Types: Full-time, Contract

Pay: $29.00 – $31.24 per hour

Benefits:

  • Health insurance

Schedule:

  • 8 hour shift
  • Day shift

Ability to commute/relocate:

  • Tarrytown, NY 10591: Reliably commute or planning to relocate before starting work (Preferred)

Application Question(s):

  • Are you an US Citizen or green card holder? What is your work Visa status?
  • Are you ready for background check and drug screen in accordance with the local law and regulations?
  • How many years of quality engineer experience do you have?
  • Do you have experience with complaint handling and Medical Device Reporting (US and Outside of the US)? How many years?
  • Good writing, communication and organizational skills necessary.

Please mention

  • What is your expected hourly rate?
  • Please confirm your email address

Work Location: One location

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