Join to apply for the post market surveillance specialist 1 role at fresenius medical care
overview
location: reynosa, tamaulipas, mexico
responsibilities
* developing professional expertise, applies company policies and procedures to resolve a variety of issues.
* interfaces with customer service and customers/patients to gather information required for complaint initiation/investigations, including retrieval of product samples or durable equipment for evaluation.
* ensure complaints from multiple sources (email, phone, verbal, fax, etc.) are entered into the complaint database.
* receive, review, and enter data into the complaint management database regarding customer/patient product inquiries and complaints using good documentation practices (gdp).
* work on problems of moderate scope, analysing factors and exercising judgment within defined procedures to determine appropriate action.
* ensure durable equipment crm technical service reports are identified as to status for transfer into the system.
* determine product and incident complaint codes based on the master symptom code severity list.
* notify customers of receipt of product inquiry/complaint and provide preliminary support as required.
* prepare other customer communications (response letters, acknowledgement letters) as appropriate.
* partner with sales, marketing, and manufacturing to resolve product problems and provide feedback to customers as needed.
* assist with timely coding of completed investigations, closure of all complaint files, and ensure all pertinent information is consistently included before closure.
* perform queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints.
* interface with corporate quality engineering and rtg manufacturing sites as required for product investigations/trends.
* adhere to the fmcna compliance program, including following all regulatory and division/company policy requirements.
* strive to meet 95% accuracy goal. Ensure data is collected through routine business processes.
qualifications
* bachelor's degree preferred, preferably in a healthcare related field.
* minimum 2–5 years of related experience in the healthcare/device industry or exposure to medical device quality system regulations; understanding of drug/device safety requirements preferred; with an advanced degree no prior experience may be considered.
* prior experience processing medical device or drug complaints preferred.
* strong interpersonal skills.
* knowledge-based pc skills: complaint management systems, crystal reports, ms access, and excel.
* familiarity with medical terminology preferred.
* english proficiency; bilingual (english/spanish) preferred.
seniority level
* mid-senior level
employment type
* full-time
job function
* quality assurance, manufacturing, and engineering
industries
* hospitals and health care
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