Post Market Surveillance Specialist

About the role

Fresenius Medical Care's Reynosa plant in Mexico manufactures disposable medical products for dialysis treatments, including hemodialysis and peritoneal dialysis disposables, machines and cyclers. As a Post Market Surveillance Specialist, you will receive, review, document and process product complaints and inquiries in line with regulations, quality standards and company procedures, working with Quality Engineering, Pharmacovigilance, Customer Service and Manufacturing teams.

Key responsibilities

• Receive, review and document product complaints and inquiries using Good Documentation Practices (GDP)
• Enter complaints from multiple sources accurately into the Complaint Management System
• Collect additional information, product samples and equipment as needed to support investigations
• Support complaint coding, investigation follow-up, trending analysis and file closure
• Partner with Quality Engineering, Manufacturing and Pharmacovigilance on product investigations and reportable events
• Ensure compliance with regulatory requirements, company policies and quality system procedures
• Maintain high data accuracy and documentation standards

Required profile

• Bachelor's degree preferred, preferably in Healthcare, Life Sciences, Engineering or a related field
• Experience with complaint handling, quality systems or medical device regulations preferred
• Fluent English and Spanish; bilingualism is required

Required skills

• Strong analytical, communication and customer service skills
• Proficiency in Microsoft Office, especially Excel
• Experience with complaint management systems and data analysis tools is a plus
• Familiarity with medical terminology preferred

What we offer

• Opportunities for self-determined career planning and professional development
• A corporate culture that encourages innovative thinking
• A team of committed professionals within a global corporation