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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 the management of information 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 increasing quality, and acting as a QA Customer Liaison to facilitate effective communication and understanding of QA processes, methodologies, and outcomes.
Key Accountabilities
* Cooperate with the Director of Quality & Regulatory Affairs - Digital Solutions to coordinate quality assurance activities for all software development products assigned.
* Ingrain quality as a core discipline into every aspect of the software development teams (Squads) organizations.
* Ensure that development teams are informed about QA processes and customer requirements, enabling the delivery of quality products and services.
* Oversee software project documents requiring QA approval, ensuring adherence to the appropriate QMS and customer processes, including requirements management, configuration control, risk analysis, verification and validation, and traceability.
* Support Change Management Board (CRB) processes as needed.
* Advance metrics and goals to provide visibility into development effectiveness from a quality perspective.
* Drive continuous improvement initiatives to enhance product quality, operational efficiency, and customer satisfaction.
* Collaborate in defining and maintaining the software development lifecycle procedures.
* Serve as the point of contact for business units/customers regarding Quality agreements.
* Participate in training and dissemination of knowledge about quality system procedures.
* Pursue a unified approach to quality process implementation across all solutions within a factory.
* Participate in software product audits and assessments as needed.
Networking/Key Relationships
Main relationships within Werfen include:
* 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 collaboration with other companies within Werfen.
Minimum Knowledge & Experience
* Education: Engineer, Computer Science or other technical degree, or equivalent work experience.
* Experience: Minimum of 5 years in a QA-related role.
* Knowledge in software development methodologies, preferably within the healthcare sector.
* Experience in creating or revising comprehensive software documentation.
* Additional Knowledge: Standards and regulations related to software development for health/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 requires a combination of technical and leadership skills in QA, ability to collaborate across teams, adaptability to evolving technologies, strong communication skills, and a commitment to fostering a quality-focused culture. Essential qualities include:
* Strong interpersonal skills and stakeholder communication.
* Flexibility and adaptability to fast-changing environments and methodologies.
* Self-organization and self-monitoring abilities.
* Proficiency in technical and conversational English.
* Commitment to continuous improvement and quality initiatives.
What We Offer
* A meaningful project impacting laboratory software medicine worldwide.
* 3 days a week remote work.
* Multicultural and friendly team environment.
* Opportunities for professional development and ongoing training.
* Social benefits including canteen, nursery checks, English training, and more, according to the chemical agreement.
Our Purpose: We contribute to advancing patient care globally through innovative diagnostics.
Join Us
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