Senior Software Quality Engineer

About the Role

Werfen is seeking a professional to join our team in a key position that contributes to our mission of improving hospital efficiency and patient care through specialized diagnostics. This role operates within our global network, collaborating across our Headquarters and Technology Centers in the US and Europe, and supporting our direct operations in 30 countries and distributor networks in over 100 territories.

Responsibilities

• Develop and implement strategies aligned with Werfen’s focus areas: Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant.
• Collaborate with cross-functional teams, including R&D, manufacturing, and quality assurance, to advance customized assays and biomaterials through our OEM business line.
• Drive innovation and quality improvements in diagnostic solutions, ensuring compliance with regulatory standards across global markets.
• Support customer-facing initiatives to strengthen commitment to healthcare providers and enhance overall customer experience.
• Analyze market trends and competitive landscape within specialized diagnostics to identify growth opportunities.
• Lead or participate in projects that optimize operational efficiency and product development timelines.

Qualifications

• Proven experience in the diagnostics, medical devices, or life sciences industry, with specific expertise in at least one of Werfen’s core areas (Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, or Transplant).
• Bachelor’s degree in a relevant scientific, engineering, or business discipline; advanced degree preferred.
• Demonstrated ability to manage complex projects with cross-functional and international teams.
• Strong analytical and problem-solving skills, with a track record of driving quality and innovation.
• Excellent communication and interpersonal skills, with the ability to engage stakeholders across diverse geographic regions.
• Willingness to travel as required to support global operations and customer engagements.

Skills

• Deep understanding of diagnostic assay development and manufacturing processes.
• Proficiency in regulatory requirements for in vitro diagnostics (IVD) in key markets (US, Europe, and others).
• Strategic thinking and business acumen, with the ability to translate market needs into product solutions.
• Fluency in English; additional languages (e.g., Spanish) are a plus.
• Strong leadership and team collaboration capabilities.