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Surveillance specialist
Biofire Diagnostics Salt Lake, UT
$43k-51k (estimate)
Full Time | Durable Manufacturing 4 Weeks Ago
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Biofire Diagnostics is Hiring a Surveillance specialist Near Salt Lake, UT

This position will review, investigate, triage and recommend escalated compliant investigations for closure. As needed, the Postmarket Surveillance Specialist II (PSS-II) will coordinate investigations with departmental teams to identify complaint cause.

The complaint investigation reports are routinely reviewed by external auditors and writing, knowledge of the subject matter and attention to detail are expected.

As guided by work instruction documents, the PSS will review the complaint investigations for medical device reporting and work with senior complaint investigation staff to assess any potential impact to the patient care.

Essential Job Duties and Responsibilties

  • Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics' Quality System.
  • Review, assess escalated customer complaints and distribute accordingly.
  • Conduct moderately complex risk investigations on escalated FilmArray complaints as part of the complaint investigation process.

Investigations may include control failures, erroneous results, known issues, etc.

  • Assess Complaint Investigation for CAPA.
  • Consult with senior members and leadership to determine if a malfunction has occurred by assessing run files, evidence gathered from the customer, manufacturing records, associated complaints, and product labeling
  • Provides support to higher risk investigations by conducting data verification, ensuring all data and information is correct and complete.
  • Determine probable cause by assessing run files, evidence gathered from the customer, manufacturing records and associated complaints.
  • Work with customer support to advise an RMA, product replacement or appropriate re-training.
  • Investigate potential for malfunction impact on patient care.
  • Triage additional investigation to departments when needed.
  • Report timeliness of complaint investigation turn around.
  • May provide administrative support and help with organizing, attending, and participating with functional group meetings.
  • Assign the appropriate risk to the Complaint Investigation tickets.
  • Performs other duties as assigned.

Qualifications

  • Bachelor's degree in Scientific Field.
  • Investigational Report Generation
  • Communication
  • Writing
  • Analytical Skills
  • Time Management
  • Ability to work independently
  • Ability to follow detailed processes
  • Knowledge of medical device regulation preferred
  • Last updated : 2024-06-04

Job Summary

JOB TYPE

Full Time

INDUSTRY

Durable Manufacturing

SALARY

$43k-51k (estimate)

POST DATE

05/23/2024

EXPIRATION DATE

06/06/2024

WEBSITE

biofiredx.com

HEADQUARTERS

SALT LAKE CITY, UT

SIZE

1,000 - 3,000

FOUNDED

1990

TYPE

Private

CEO

RANDY RASMUSSEN

REVENUE

$50M - $200M

INDUSTRY

Durable Manufacturing

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About Biofire Diagnostics

BioFire Diagnostics is a clinical diagnostics company.

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The following is the career advancement route for Surveillance specialist positions, which can be used as a reference in future career path planning. As a Surveillance specialist, it can be promoted into senior positions as a Surveillance Supervisor that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Surveillance specialist. You can explore the career advancement for a Surveillance specialist below and select your interested title to get hiring information.