Senior Software Quality Engineer

About the Position

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.

The Senior Software Quality Engineer is responsible for ensuring that activities throughout the product lifecycle are in compliance with procedures, standards and regulations applicable to our products. In this capacity, the individual independently develops, applies, and implements methods, tools and practices while working with project teams to achieve product quality goals and requirements in the areas of design, development, cybersecurity, verification and validation, maintenance and service.

This is a technically focused role requiring advanced skills in analyzing information, reviewing technical reports, promoting process improvement, requirements development, risk management, product development, verification and validation, and cybersecurity.

• Participate in the generation of quality documents throughout the product lifecycle.
• Advise and direct teams regarding compliance to procedures, standards, and regulations, and implement changes to procedures in alignment with evolving regulations.
• Ensure product quality meets requirements and documentation is complete prior to approval.
• Participate on core teams supporting new product development or design changes.
• Review and approve quality documents throughout the product lifecycle.
• Support audits and corrective actions to improve and maintain compliance of the QMS.
• Identify compliance gaps and take appropriate corrective actions as needed.
• Participate in and may lead quality system improvement projects as required.
• Perform other duties and responsibilities as assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Internal networking and key relationships include interaction with other functions to generate compliant documents by interpreting and explaining quality procedures, applicable standards, regulations, and best practices; effective communication of quality requirements to a broad population of constituents; and the ability to negotiate and influence others toward improved quality and enhanced compliance.

Skills & capabilities:

• Working knowledge of domestic and international quality/regulatory standards related to our products.
• Knowledge of quality management techniques (Lean, Six Sigma) and statistical techniques required to measure and confirm significant changes.
• Working knowledge of products, technology, and manufacturing processes including impact on customers and patient requirements.

Demonstrate judgement commensurate with experience regarding application of regulatory requirements to data review, reports, design changes, risk management, etc. to ensure compliance and achieve business objectives. Demonstrated understanding of risk‑based approach to processes and decisions.

Education:

Bachelor's degree or equivalent in engineering or science.

Experience:

A minimum of 8 years of experience in medical devices, pharmaceuticals, diagnostic industry, or clinical laboratory of 5 years of experience. Management has discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

International mobility required:
No

Travel requirements:
Approximately 10%

The annual base…