Post Market Surveillance Specialist

Fresenius Medical Care; Reynosa; Presencial; MXN 350.000 - 480.000; Jornada completa

Descripción de la vacante

Fresenius Medical Care in Reynosa, Mexico seeks a Post Market Surveillance Specialist to review, document, and process product complaints in compliance with regulations and company procedures. You will collaborate with Quality Engineering, Pharmacovigilance, Customer Service, and Manufacturing to support investigations and reporting.

The role requires bilingual English and Spanish communication, strong analytical skills, and experience with quality systems and data analysis.

Formación

• Bachelor’s Degree preferred in healthcare, life sciences, engineering, or related field.
• Experience with complaint handling, quality systems, or medical device regulations preferred.
• Strong analytic, communication, and customer service skills.
• Proficiency in Microsoft Office applications, particularly Excel.
• Experience with complaint management systems and data analysis tools is a plus.
• Familiarity with medical terminology preferred.
• Fluent English and Spanish (bilingual required).

Responsabilidades

• Receive, review, and document product complaints and inquiries using GDP.
• Ensure complaints from multiple sources are accurately entered 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 complaint file closure.
• Partner with Quality Engineering, Manufacturing, and Pharmacovigilance teams on product investigations and reportable events.
• Ensure compliance with regulatory requirements, company policies, and quality system procedures.
• Maintain high data accuracy and documentation standards.

Conocimientos

Analytical skills

Communication skills

Customer service

Bilingual English/Spanish

Educación

Bachelor's degree in Healthcare/Life Sciences/Engineering

Herramientas

Complaint Management System

Descripción del empleo

Post Market Surveillance Specialist

At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey.

Guided by our vision—“Creating a future worth living. For patients. Worldwide. Every day”—we work with purpose and compassion, supported by a global team of over 110,000 employees.

Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth.

Our values guide how we work:

• We Care for our patients, each other, and our communities
• We Connect across teams and borders to deliver excellence together
• We Commit to doing things the right way—growing with purpose and leading kidney care with integrity and innovation

At our Reynosa plant in Mexico, we are committed to the highest standards in the production of disposable medical products for dialysis treatments. With a dedicated team of more than 3,000 employees across four manufacturing sites, the plant focuses on manufacturing essential components such as hemodialysis disposables, peritoneal dialysis (PD) disposables, hemodialysis (HD) machines, and PD cycler machines.

By utilizing advanced technologies to ensure the highest standards in dialysis product manufacturing, we’re not only driving innovation—we’re also creating meaningful change for patients worldwide. Join our passionate team and be part of this global impact.

As a Post Market Surveillance Specialist, you will be responsible for receiving, reviewing, documenting, and processing product complaints and inquiries in compliance with applicable regulations, quality standards, and company procedures. You will collaborate with Quality Engineering, Pharmacovigilance, Customer Service, and Manufacturing teams to support investigations, trending, and complaint resolution.

Key Responsibilities

• Receive, review, and document product complaints and inquiries using Good Documentation Practices (GDP).
• Ensure complaints from multiple sources are accurately entered 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 complaint file closure.
• Partner with Quality Engineering, Manufacturing, and Pharmacovigilance teams on product investigations and reportable events.
• Ensure compliance with regulatory requirements, company policies, and quality system procedures.
• Maintain high data accuracy and documentation standards.

Qualifications

• Bachelor’s Degree preferred, preferably in a Healthcare, Life Sciences, Engineering, or related field.
• Experience with complaint handling, quality systems, or medical device regulations preferred.
• Strong analytic, communication, and customer service skills.
• Proficiency in Microsoft Office applications, particularly Excel.
• Experience with complaint management systems and data analysis tools is a plus.
• Familiarity with medical terminology preferred.
• Fluent English and Spanish (Bilingual required).

Our Offer for You

• There is a lot you can discover at Fresenius Medical Care, regardless of the field of expertise or level of experience—everything is dedicated to supporting your professional journey.
• Whether in front of or behind the scenes, you help make better medicine available to more people worldwide
• Individual opportunities for self‑determined career planning and professional development
• A corporate culture that encourages innovative thinking—finding the best solution together, not just the fastest one
• A team of committed professionals with diverse skills, talents, and experiences
• The strength of a successful global corporation combined with the collegial culture of a mid‑sized company