Senior QA Lead - Clinical Software

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. We operate directly in 30 countries, and in more than 100 territories through distributors.

Our Headquarters are in Barcelona, Spain and our Technology Centers are located in the United States and Europe. Worldwide sales exceeded €2.2 billion in 2024, and our workforce is more than 7,000 strong.

JOB SUMMARY

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, including providing inputs and active contributions to the definition and maintenance of the Quality Management System (QMS). Working closely with the Solutions Leaders to ensure to deliver software releases with an ever-increasing level of quality.

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

KEY ACCOUNTABILITIES

· Cooperating with the Director of Quality & Regulatory Affairs - Digital Solutions to co-ordinate quality assurance activities for all SW development products assigned.

· 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 with the perspective 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 the setting of goals that provide visibility and understanding of development effectiveness from a quality perspective.

· Drive 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. Provides input in the implementation of the process.

· Point of contact for the different business unit's / client related with Quality agreements

· Take an active role in the training and dissemination of knowledge regarding quality system procedures.

· Pursuing a unified approach to quality process implementation throughout the software development lifecycle across all solutions within a Factory.

· Participate in software products audits and assessments as needed.

NETWORKING/ KEY RELATIONSHIPS

The main relationships within the Werfen Group are:

· Factory Lead and Solution Leaders

· Solutions QA Leaders from other factories

· SW Development Teams (Squads) and Chapter Leads

· QARA Manager and QARA Specialist

· Customer

· Validation Lead

· Application Lifecycle manager (ALM)

· This position may also require cooperating with other companies inside Werfen.

EXPERIENCE:

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

· Experience:

o A minimum of 5 years of experience in a QA related role.

o Knowledge in SW Development methodologies preferably within the Healthcare sector.

o Experience in the creation or revision of comprehensive software products documentation.

· Additional Skills/Knowledge:

o Knowledge about applicable standards and regulations related with SW development for Health and/or Medical Device. (ISO 13485, ISO 14971, IEC 62304, IEC 82304, ISO 62366, cybersecurity)

o Familiar with medical device regulations (MDR/IVDR, FDA, etc)

SKILLS AND CAPABILITIES:

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

Besides it is needed to have:

· Strong interpersonal skills with a proven ability to collaborate across teams and communicate effectively with stakeholders.

· Flexibility and adaptability to a fast-changing environment/methodology

· Self-organized and self-monitor to be able to report the effort dedicated to each individual tasks inside all the different responsibilities.

· Good level of Technical and Conversational English

· Commitment to continuous improvement, with a track record of implementing initiatives to enhance overall quality processes.

TRAVEL REQUIREMENTS:

5% of time