Postmarket Surveillance Specialist II

bioMerieux Inc.
United States, Utah, Salt Lake City
Dec 19, 2024
Postmarket Surveillance Specialist II Location: Salt Lake City, UT, United States Position Type: Unfixed Term Job Function: Quality Share: share to e-mail Share on Facebookshare to facebook Tweetshare to twitter Share on LinkedInshare to linkedin Apply Now > A world leader in the field of in vitro diagnostics for more than 60 years, bioMerieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 6,200 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada. Come and join a family-owned global company with a long-term vision, and a human-centered culture. Description Description of Responsibilities Position Summary 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. Primary Duties Reviews and assesses escalated customer complaints. Conducts moderately complex risk investigations on escalated BIOFIRE complaints as part of the complaint investigation process. Investigations may include control failures, erroneous results, known issues, etc. Assesses complaint investigations for CAPA. Consults 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. Determines probable cause by assessing run files, evidence fathered from the customer, manufacturing records, and associated complaints. Works with customer support to advise on RMA, product replacement, or appropriate re-training. Investigates potential for malfunction impact on patient care. Triages additional investigation to other departments when needed. Completes Complaint Investigations in a timeline manner. May provide administrative support and helps with organizing, attending, and participating with functional group meetings. Assigns the appropriate risk to Complaint Investigation tickets. Performs all work in compliance with company quality procedures and standards. Performs other duties as assigned. Qualifications Training and Education Bachelor's degree in a scientific field. Experience Minimum 3 years troubleshooting of molecular or microbiological diagnostic test or clinical lab experience is preferable. Knowledge, Skills, and Abilities 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, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at recruitment@biomerieux.com. BioMerieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMerieux's or its affiliates' application process by contacting us via telephone at (385) 770-1132, by email at recruitment@biomerieux.com, or by dialing 711 for access to Telecommunications Relay Services (TRS). Share: share to e-mail Share on Facebookshare to facebook Tweetshare to twitter Share on LinkedInshare to linkedin Apply Now >