Fresenius Medical Care North America is hiring a Post Market Surveillance Specialist 1

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.