Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. 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 SUMMARYSolutions 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 ACCOUNTABILITIESCooperating 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. Point of contact for the different business unit's / client related with Quality agreementsTake 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 RELATIONSHIPSThe main relationships within the Werfen Group are: Factory Lead and Solution LeadersSolutions QA Leaders from other factoriesSW Development Teams (Squads) and Chapter LeadsQARA Manager and QARA SpecialistCustomerValidation LeadApplication Lifecycle manager (ALM)This position may also require cooperating with other companies inside Werfen.

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

Experience in the creation or revision of comprehensive software products documentation. 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)Familiar with medical device regulations (MDR/IVDR, FDA, etc)SKILLS AND CAPABILITIESThis 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.

Good level of Technical and Conversational EnglishCommitment to continuous improvement, with a track record of implementing initiatives to enhance overall quality processes.

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