• 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.
• 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.
• Point of contact for the different business unit´s / client Related with Quality agreements.
• 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.
• QARA Specialist.|Pharma Company (Vallés Or.).
• A minimum of 5 years of experience in a QA related role.
• Knowledge in SW Development methodologies preferably within the Healthcare sector.
• Experience in the creation or revision of comprehensive software products documentation.
• Advanced skills in defining and analyzing metrics, overseeing, and monitoring processes, creating reports and status updates.
• Understanding and practical experience in managing customer needs and the ability to align QA processes with customer expectations.
• 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, MDR/IVDR, FDA, etc).
• Ability to conduct root cause analysis investigations and implement corrective and preventive actions.
• Experience conducting risk assessments and implementing risk mitigation strategies to ensure product quality and reliability.
Pharma Leader Company.
• Permanent Contract.
• Competitive Salary.
• 3 days a week working from home.
• Flexible Schedule.
• Multicultural and friendly team.
• Exciting opportunities for professional development.
• Ongoing training.
• Multiple Social benefits: Canteen, health insurance, nursery check, English training...
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