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Quality Analyst - NxStage

Lawrence, Massachusetts
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Job ID 19000ON2

Available Openings 1

Position Specific Information

NxStage Medical, a Fresenius Company is on a mission to transform renal care. To do that, we continually seek the best-of-the-best to expand and improve our team of dedicated, innovative professionals. If you share our mission and are committed to improving the lives of renal patients, then we invite you to explore our career opportunities.




PURPOSE AND SCOPE:

The incumbent will be responsible for receiving and processing customer product complaints in Fresenius/NxStage’s postmarket surveillance department with a primary focus on performing functions in support of the quality engineering and clinical teams.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • 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 AND SKILLS:

  • 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 Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.