Senior Quality Engineer, Risk Management

About the Position

Werfen

Werfen is a growing, family‑owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors.

Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Position Summary:

The position is responsible for ensuring that Design Control and Risk Management activities throughout the product lifecycle are in compliance with procedures, standards and regulations applicable to our products. This position provides project‑level leadership, independently develops, applies and implements methods, tools and practices to achieve product quality and compliance goals in the areas of design, development, risk management, production, distribution, maintenance and service.

Candidates for the position are expected to lead by example, in alignment with company values.

• Serve as the risk management expert for all product development activities, ensuring compliance with applicable design control, risk management, usability, and regulatory requirements for IVD, Medical Device, SaMD and SiMD products.
• Own the development, maintenance, and continuous improvement of product Risk Management deliverables, ensuring alignment with ISO 14971, integration of post‑market feedback, and a proactive focus on patient safety throughout the product lifecycle.
• Influence project direction and technical decision‑making by embedding quality, compliance, risk controls, and patient safety requirements into product architecture, system requirements, verification and validation (V&V) strategies, and lifecycle management activities.
• Lead complex investigations and root cause analyses using structured methodologies to ensure that escalations, investigations and corrective/preventative actions (CAPA) are taken to remediate negative trends, prioritizing patient safety and quality.
• Provide input to failure investigations, complaint analysis, health hazard evaluations, and correction and removal activities.
• Support internal and external audits. Contribute to regulatory responses and documentation required by FDA, notified bodies, and other competent authorities.
• Build relationships with R&D, Manufacturing, Regulatory, Service, and Marketing partners, providing clear communication to senior leadership on quality risks, mitigations strategies, and program status.
• Provide guidance to quality engineers and cross‑functional partners on risk management principles, design assurance practices, quality engineering tools and problem‑solving methodologies.
• Perform other duties as assigned to support departmental and organizational objectives.

• Identify compliance gaps and drive appropriate corrective actions as needed.
• Lead quality system improvement projects as required.

• R&D
• Operations
• Manufacturing Engineering
• Regulatory Affairs
• Service/Marketing
• Medical Affairs

The ideal candidate for this position will exhibit the following skills and capabilities:

• Deep knowledge of domestic and international quality/regulatory standards related Medical Devices and both Software in and Software as a Medical Device.
• In depth knowledge of quality management techniques (Lean, Six Sigma) and statistical techniques required to measure and confirm significant changes.
• Broad and thorough knowledge of engineering and science theory and principles, including R&D, quality control, manufacturing and design…