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.
The Post Market Surveillance Specialist role focuses on post‑market quality oversight combined with a comprehensive understanding of regulatory complaint management processes. This position manages product inquiries and complaints across the full product portfolio—including medical devices, drugs, and equipment—in full compliance with FDA, ISO, and internal quality system requirements.
The role is responsible for complaint intake, documentation, investigation coordination, and trend analysis, partnering closely with Pharmacovigilance and Corporate Quality Engineering to support patient safety, regulatory reporting, and continuous improvement of products manufactured and distributed by Fresenius Medical Care.
Responsibilities
- Develop professional expertise and apply company policies and procedures to resolve a variety of product‑related issues.
- Interface with Customer Service and customers/patients to gather additional information required for complaint initiation and investigation, including coordination of product samples or durable equipment retrieval for evaluation.
- Ensure that complaints received from multiple sources (email, phone, verbal communication, fax, etc.) are properly entered into the complaint management database.
- Receive, review, and accurately enter customer and patient product inquiries and complaints using Good Documentation Practices (GDP).
- Address issues of moderate complexity where analysis involves reviewing multiple data points and factors; exercise judgment within established procedures.
- Ensure durable equipment CRM Technical Service reports are correctly identified and transferred into the complaint management system.
- Assign appropriate product and incident complaint codes based on the master symptom code severity list.
- Notify customers of receipt of product inquiries or complaints and provide preliminary support as required.
- Prepare customer communications such as acknowledgement letters and response letters, as appropriate.
- Collaborate with Sales, Marketing, Manufacturing, and other departments to resolve product issues and provide customer feedback.
- Support the review of completed investigations to ensure timely coding, consistent documentation, and proper closure of complaint files.
- Perform database queries and provide complaint data and ad‑hoc trend analysis on reported product problems.
- Interface with Corporate Quality Engineering and manufacturing sites to support product investigations and trend evaluations.
- Adhere to the FMCNA Compliance Program, FDA regulations, and all applicable company and divisional policies.
- Strive to meet established accuracy goals (95% accuracy target) and ensure proper data collection through routine business processes.
Qualifications
- Bachelor’s degree preferred, ideally in a healthcare‑related field.
- Minimum of 2–5 years of experience in the healthcare or medical device industry, or exposure to medical device quality system regulations.
- With an advanced degree, limited prior experience may be considered.
- Prior experience processing medical device or pharmaceutical complaints preferred.
- Strong interpersonal and communication skills.
- Proficiency with PC‑based systems, including complaint management systems, Crystal Reports, MS Access, and Excel.
- Familiarity with medical terminology preferred.
- Bilingual English/Spanish; fluency in English 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
