Fresenius Medical Care North America is looking for a Post Market Surveillance Specialist 1 to join our team. In this role, you will be responsible for receiving, reviewing, and entering customer and patient product inquiries and complaints into our complaint database. You will serve as a key interface point to gather information for investigations and ensure complaint files are properly managed and closed.
What You'll Do
- Apply company policies and procedures to resolve issues.
- Interface with Customer Service and customers/patients to gather information for complaint initiation and investigations, including retrieving product or equipment samples.
- Enter complaints from multiple sources—such as email, phone, verbal, and fax—into the complaint database.
- Receive, review, and enter data into the Complaint Management Database using good documentation practices (GDP).
- Work on problems of moderate scope, exercising judgment within defined procedures.
- Ensure durable Equipment CRM Technical Service reports are correctly identified 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 inquiries/complaints and provide preliminary support.
- Prepare customer communication, including response letters and acknowledgement letters.
- Partner with sales, marketing, and manufacturing departments to resolve product problems and provide customer feedback.
- Assist with the review of completed investigations, closure of complaint files, and ensure information is consistent.
- Perform queries to provide complaint data and ad hoc trend analysis.
- Interface with Corporate Quality Engineering and RTG manufacturing sites for product investigations and trends.
- Adhere to the FMCNA Compliance Program and all regulatory and company policy requirements.
- Strive to meet Accuracy Goals (95% accuracy goal).
What We're Looking For
- A minimum of 2–5 years of related experience in the healthcare/device industry or exposure to medical device quality system regulations.
- Strong interpersonal skills.
- Knowledge-based PC computer skills are essential.
- Fluency in English.
Nice to Have
- Bachelor's degree, preferably in a healthcare related field.
- Understanding of drug/device safety requirements.
- Prior experience processing medical device or drug complaints.
- Familiarity with medical terminology.
- Bilingual proficiency in English and Spanish.
Technical Stack
- Industry recognized complaint management systems.
- Crystal reporting.
- MS Access.
- MS Excel.
Fresenius Medical Care North America is an equal opportunity employer.
