Quality Analyst - NxStage

Acumen Physician Solutions in Lawrence, MA

  • Type: Full Time
position filled

PURPOSE AND SCOPE:

The incumbent will be responsiblefor receiving and processing customer product complaints in Fresenius/NxStage’s postmarketsurveillance department with a primary focus on performing functions in supportof the quality engineering and clinical teams.

PRINCIPAL DUTIES ANDRESPONSIBILITIES:

  • Process incoming customer complaints and adverse events as assigned for device and drug-related incidents
  • Interface with distributor contacts and customer clinical staff to obtain detailed information regarding reported incidents as required, ensuring patient confidentiality throughout
  • Prepare weekly and monthly complaint activity reports and metrics for management review as assigned
  • Consult with Fresenius/NxStage clinical, quality, and other staff as required.
  • Assist in gathering pertinent data for complaint investigation as assigned.
  • Database maintenance and support as assigned
  • Adhoc report creation as assigned
  • Full adherence to Fresenius/NxStage complaint handling policies and procedures
  • Other duties as assigned


    PREFERRED EXPERIENCE ANDSKILLS:

  • 1 – 3 years’ related experience; or a bachelor’s degree without experience; or equivalent directly related work experience
  • Ability to read, analyze, and interpret customer complaints and medical terminology quickly and accurately
  • Ability to perform rote tasks with a high level of consistency.
  • Exceptional attention to detail and follow-through skills
  • Ability to work well independently and as a member of a team
  • Microsoft Office, including intermediate Excel skills
  • Desired: Prior experience with AssurX CATSWeb quality management software and/or querying with SQL
  • Desired: Prior experience with Salesforce CRM or Birst Business Intelligence
  • Desired: Prior experience with Medical Device or Pharmaceutical Manufacturing Quality Systems, including but not limited to 21 CFR 820 and/or 21 CFR 201/211
  • EO/AA Employer:Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

    Fresenius Medical CareNorth America maintains a drug-free workplace in accordance with applicablefederal and state laws.



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