Senior Qa Leader

buscojobs España; Barcelona; Presencial; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

Ein innovatives Unternehmen sucht einen Solutions QA Leader, um die Qualität in der Softwareentwicklung zu verbessern. Diese Rolle erfordert enge Zusammenarbeit mit verschiedenen Teams, um sicherzustellen, dass Produkte den höchsten Qualitätsstandards entsprechen. Sie werden die Qualität als Kernkompetenz in allen Teams verankern und die Einhaltung von Vorschriften und Standards vorantreiben. In einem multikulturellen Team mit flexiblen Arbeitsbedingungen haben Sie die Möglichkeit, an bedeutenden Projekten zu arbeiten, die die Qualität von Laborsystemen weltweit beeinflussen. Wenn Sie eine Leidenschaft für Qualität und kontinuierliche Verbesserung haben, ist dies die perfekte Gelegenheit für Sie.

Servicios

3 Tage Homeoffice pro Woche

Multikulturelles Team

Berufliche Weiterbildung

Soziale Leistungen

Kantine

Englischtraining

Formación

• Mindestens 5 Jahre Erfahrung in einer QA-Rolle, vorzugsweise im Gesundheitswesen.
• Kenntnisse über Softwareentwicklungsstandards und -vorschriften.

Responsabilidades

• Koordination der Qualitätssicherungsaktivitäten für Softwareentwicklungsprodukte.
• Förderung kontinuierlicher Verbesserungsinitiativen zur Produktqualität.

Conocimientos

Qualitätsmanagement

Softwareentwicklung

ISO 13485

ISO 14971

IEC 62304

Kommunikationsfähigkeiten

Englischkenntnisse

Selbstorganisation

Educación

Ingenieur oder Informatikabschluss

Descripción del empleo

At Werfen, in the Clinical Software Business Unit, we are committed to developing secure, efficient, and innovative clinical applications and laboratory instrumentation systems. Our solutions enhance patient care and facilitate information management in hospitals and laboratories worldwide.

Solutions QA Leader focuses on organizational aspects of quality management, aiming to improve the end-to-end product development lifecycle, from requirements analysis to launch and maintenance. The role involves working closely with Solutions Leaders to ensure the delivery of software releases with an increasing level of quality. When applicable, the QA Customer Liaison facilitates effective communication and understanding of QA processes, methodologies, and outcomes.

Key Accountabilities

1. Cooperate with the Director of Quality & Regulatory Affairs - Digital Solutions to coordinate quality assurance activities for all software development products.
2. Ingrain quality as a core discipline within all software development teams (Squads).
3. Ensure development teams are informed about QA processes and customer requirements to deliver quality products or services.
4. Oversee software project documents subject to QA approval, ensuring adherence to the QMS and customer processes, including requirements management, configuration control, secure design, risk analysis, verification and validation, and traceability.
5. Support Change Management Board (CRB) processes as needed.
6. Advance metrics and set goals to provide visibility into development effectiveness from a quality perspective.
7. Promote continuous improvement initiatives to enhance product quality, operational efficiency, and customer satisfaction.
8. Collaborate on defining and maintaining software development lifecycle procedures.
9. Act as the point of contact for business units/customers regarding Quality agreements.
10. Participate in training and dissemination of knowledge related to quality system procedures.
11. Implement a unified approach to quality processes throughout the software development lifecycle across all solutions within a factory.
12. Participate in software product audits and assessments as needed.

Networking / Key Relationships

The main relationships within the Werfen Group are with:

• Factory Lead and Solution Leaders
• Solutions QA Leaders from other factories
• Software Development Teams (Squads) and Chapter Leads
• QARA Manager and QARA Specialist
• Customer Validation Lead
• Application Lifecycle Manager (ALM)

This position may also require cooperation with other companies within Werfen.

Minimum Knowledge & Experience

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

Experience: At least 5 years in a QA-related role, with knowledge of software development methodologies, preferably within the healthcare sector. Experience in creating or revising comprehensive software documentation.

Additional Skills / Knowledge: Knowledge of applicable standards and regulations related to software development for health and/or medical devices (ISO 13485, ISO 14971, IEC 62304, IEC 82304, ISO 62366, cybersecurity). Familiarity with medical device regulations (MDR/IVDR, FDA).

Skills & Capabilities

This role combines technical and leadership experience in QA, requiring collaboration with cross-functional teams to ensure product quality and compliance. The candidate must demonstrate adaptability, strong communication skills, and a commitment to fostering a quality-focused culture. Essential qualities include:

• Strong interpersonal skills for effective stakeholder communication.
• Flexibility and adaptability to a fast-changing environment.
• Self-organization and self-monitoring to report effort on tasks.
• Proficiency in technical and conversational English.
• Commitment to continuous improvement with a proven track record of enhancing quality processes.

What We Offer

• A meaningful project impacting laboratory software quality worldwide.
• 3 days a week working from home.
• Multicultural and friendly team environment.
• Opportunities for professional development and ongoing training.
• Social benefits including canteen, nursery checks, and English training, among others, according to the chemical agreement.

Our Purpose

We contribute to advancing patient care globally through innovative specialized diagnostics.