Senior QA Leader

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.

Overview

The Solutions QA Leader focuses on organizational aspects of quality management, aiming to improve the end-to-end product development life cycle, from requirements analysis to launch and maintenance. Working closely with the Solutions Leaders to ensure the delivery of software releases with an ever-increasing level of quality.

When applicable, the QA Customer Liaison facilitates effective communication and understanding of QA processes, methodologies, and outcomes.

Responsibilities

Key Accountabilities

Be a key part of a team where you will :

• Cooperate with the Director of Quality & Regulatory Affairs - Digital Solutions to coordinate quality assurance activities for all SW development products assigned.
• Be responsible for ingraining quality as a core discipline into every aspect of the SW development teams (Squads) organizations.
• Ensure that SW Development teams (Squads) are informed of the QA processes and / or customer requirements enabling the delivery of a product or service to an agreed level of quality.
• Oversee SW project documents subject to QA approval ensuring the establishment and adherence to the appropriate QMS and customer processes and procedures, including but not limited to requirements management, configuration control, secure design, risk analysis, verification and validation, traceability, etc.
• Support Change Management Board (CRB) process as needed.
• Advance metrics and set goals that provide visibility and understanding of development effectiveness from a quality perspective.
• Drive and promote continuous improvement initiatives to enhance product quality, operational efficiency, and customer satisfaction.
• Collaborate in the QS software development life cycle procedures definition and maintenance. Provide input in the implementation of the process.
• Be the point of contact for the different business units / clients related to Quality agreements.
• Take an active role in the training and dissemination of knowledge regarding quality system procedures.
• Pursue a unified approach to quality process implementation throughout the software development lifecycle across all solutions within a Factory.
• Participate in software product audits and assessments as needed.

Networking / Key relationships

The main relationships within the Werfen Group are :

Qualifications

Education : Engineer, Computer Science or other Technical degree, or equivalent work experience.

Experience :

Additional Skills / Knowledge :

Skills & Capabilities :

This position requires a combination of technical and leadership experience in QA, being able to collaborate seamlessly with cross-functional teams to ensure product quality and customer and regulatory compliance. The role demonstrates adaptability to evolving technologies, strong communication skills, and a commitment to fostering a quality-focused culture within the organization.

Additionally, it is necessary to have :

If you are interested in constantly learning and being challenged daily, we encourage you to submit your resume or CV.

Werfen appreciates and values diversity. We are an Equal Opportunity / Affirmative Action Employer M / F / D / V.

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