Social network you want to login/join with:
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 and technology centers are located in Europe and the United States, and our workforce is more than 7,000 strong.
In Werfen, our purpose is to contribute to the advancement of patient care around the world through innovative specialized diagnostics solutions.
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 around the world.
We are looking for a ALM Tool Specialist
Job Summary
This position focuses on activities related to the implementation, monitoring, and maintenance of Application Lifecycle Management (ALM) support tools as a medical device manufacturer.
Key processes covered by these tools include software requirements definition and management, change and configuration management, project planning with a focus on agile methodologies, quality management including defect and risk management, data reporting, workflow mapping, integration with version control, wikis, collaboration tools, and other ALM tools. Governance and validation of these tools to meet medical device development standards are also crucial.
Key Accountabilities
* Implementing the company's QMS in ALM tools.
* Coordinating with QA and Solution Leaders to align ALM with evolving QMS.
* Managing user access and licenses.
* Leading validation efforts to ensure compliance with medical device standards.
* Managing infrastructure and vendor relationships related to ALM tools.
* Applying strategies to harmonize concepts and reduce maintenance efforts.
* Participating in ALM governance and evolution initiatives across Werfen.
Networking/Key relationships
* Collaborate with project teams to identify and implement ALM needs and improvements.
* Coordinate with IT for hosting and networking infrastructure.
* Work with external service providers to enhance service quality.
Minimum Knowledge & Experience
* Engineer BS or MS, or equivalent in Computer Science or related technical field.
* At least 3 years of experience as an ALM specialist.
* Strong understanding of Agile methodologies.
* Knowledge of medical device regulations (ISO 13485, ISO 14971) and software lifecycle standards (IEC 62304).
* Experience with JIRA, Confluence, and JAMA.
Skills & Capabilities
* Proficient in English, both technical and conversational.
* Team player with independent working skills.
* Excellent interpersonal, judgment, and analytical skills.
* Effective time management and organizational skills.
#J-18808-Ljbffr