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Quality Professional

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  • ID: 462925
  • Posted: 6/3/2020
  • Location: Newark, DE
  • Category: Pro - Professional
  • Job Type: Temporary
  • Duration: 9 - 12 Months

Description

Acara solutions is looking for Quality Professional for our Client located in Newark, DE.
  • Evaluate safety complaint escalations and make decisions on Medical Device Reporting (MDR), fully documenting those decisions.
  • File MDRs and communicate as appropriate to the Authorized Representative or Regional Unit.
  • Work with the Designated Complaint Handling Unit (DCU) and Medical Affairs to review and assess and close potentially adverse events (pMDRs), including MDR reporting related to Atellica/Dimension systems /Dimension Vista systems and assays/Informatics systems.
  • Provide support in all areas associated with MDR/MDVR/MDPR reporting and trending.
  • In addition, support the Commercial Product Quality department when working on post market Atellica/Dimension/Dimension Vista systems and assays and Informatics system related issues from the Escalation Review Council (ERC).
  • Provide Commercial Product Quality support for the above mentioned systems Product Health Teams.
  • Provide Commercial Product Quality support for external audits (LRQA, FDA, etc.).
  • 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:
  • Bachelor’s degree (BS/BA) in Medical Technology or Biomedical Engineering.
  • Minimum of 4 years’ experience in Quality Systems and Medical Device Reporting.
Preferred Skills / Qualifications:
  •  A significant knowledge of organization's business practices, issues faced and contributions to problem resolution of those issues.
  • Good writing, communication and organizational skills necessary.
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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