Quality Associate II

About the Role

Werfen is seeking a professional to join our team in a key position supporting our diagnostic solutions. This role contributes to our mission of improving hospital efficiency and patient care through specialized diagnostics.

Responsibilities

• Develop and implement strategies to support Werfen's diagnostic product lines in Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant
• Collaborate with cross-functional teams including R&D, manufacturing, and commercial operations to drive business objectives
• Manage relationships with distributors and direct customers across multiple territories
• Provide technical and clinical support to healthcare professionals using Werfen diagnostic solutions
• Analyze market trends and competitive landscape to identify growth opportunities
• Ensure quality standards and regulatory compliance across all business activities
• Participate in product development and improvement initiatives through OEM business line activities

Requirements

• Bachelor's degree in Life Sciences, Business, or related field
• Minimum 5 years of experience in diagnostic, medical device, or healthcare industry
• Proven track record in commercial, technical, or operational roles within specialized diagnostics
• Experience working in international or multi-cultural environments
• Strong understanding of hospital laboratory operations and diagnostic workflows
• Excellent communication and presentation skills
• Ability to travel as needed to support business activities across Werfen's global operations

Qualifications

• Advanced degree (MBA, MS, or PhD) in relevant field preferred
• Specific expertise in one or more of Werfen's core diagnostic areas: Hemostasis, Acute Care, Transfusion, Autoimmunity, or Transplant
• Experience with OEM manufacturing or custom assay development
• Knowledge of regulatory requirements for in vitro diagnostics (IVD) in US and European markets
• Multilingual capabilities, particularly Spanish or other European languages

Skills

• Strategic thinking and business acumen
• Project management and organizational skills
• Data analysis and interpretation
• Relationship building and stakeholder management
• Adaptability and problem-solving in complex environments
• Commitment to quality and continuous improvement