Postmarket Surveillance Specialist II

Location: Salt Lake City, UT, United States Position Type: Unfixed Term Job Function: Clinical Affairs

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A family-owned company, bioMerieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

Description 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.
• Minimum 3 years troubleshooting of molecular or microbiological diagnostic test or clinical lab experience is preferable.
• Investigational Report Generation
• Communication
• Writing
• Analytical Skills
• Time Management
• Ability to work independently
• Ability to follow detailed processes
• Knowledge of medical device regulation preferred

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMerieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam,... For full info follow application link.