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Werfen Immunoassay

Market Surveillance Engineer

hace 3 días

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At Werfen, a global leader in in-vitro diagnostics, we are looking for a Market Surveillance Engineer to join the team. This role is ideal for a scientifically minded professional who enjoys investigating customer complaints, analyzing post-market data, and identifying trends to ensure product safety and compliance. You will collaborate across functions—including Quality, Regulatory, and Operations—in a highly regulated, quality-driven environment , acting as a key point of contact for customers and regulatory authorities. About the Role We are looking for a proactive Market Surveillance Engineer to join our Quality Operations team within the QRA department. This role is critical for ensuring the safety, compliance, and performance of our diagnostic products in the market. The ideal candidate will combine technical expertise, regulatory knowledge, and strong problem-solving skills to manage post-market activities effectively. You will act as the primary contact for customer complaints, coordinate investigations, perform risk assessments, and ensure timely communication of any field actions. Your work will directly support compliance with global vigilance and post-market surveillance regulations. What You Will Do Receive, investigate, and manage customer complaints using SAP, coordinating with internal teams. Conduct risk analysis and determine if field actions are required. Prepare and communicate investigation reports to customers and regulatory authorities. Monitor post-market performance trends and provide insights for continuous improvement. Manage product samples and kits used in investigations, maintaining proper documentation. Ensure compliance with internal SOPs, quality standards, and regulatory requirements. Track market surveillance metrics and report to Quality Operations leadership. Stay updated with regulatory notifications from health authorities and industry sources (e.g., MAUDE, Health Canada, Health Australia). Support internal and external audits related to post-market activities. Key Relationships Collaborate with cross-functional teams including Quality, Regulatory, and Operations. Serve as a point of contact for customers, distributors, and external laboratories. Interface with other Werfen group companies to share complaints status and surveillance reports. What We’re Looking For Education & Experience Bachelor’s degree in Biotechnology, Life Sciences, or related field. Relevant work experience may substitute for formal education. Minimum 3 years in a similar post-market, regulatory, or quality role. Skills & Knowledge Strong understanding of quality and regulatory standards applicable to diagnostic products. Proficiency in SAP and MS Office (Excel, Word). Fluency in Spanish or Catalan and advanced English (written & spoken). Experience with risk analysis, health hazard evaluations, and field actions. Personal Attributes Methodical, organized, and detail-oriented. Ability to manage decisions under pressure and meet deadlines. Strong teamwork, communication, and interpersonal skills. Capacity to adapt to change, influence others, and drive results independently. Why Join Us? Work in a collaborative, supportive team environment with a strong culture. Gain hands-on experience with cutting-edge diagnostic products. Engage with international customers and regulatory authorities. Contribute to meaningful work ensuring product safety and compliance worldwide.

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