Senior QA Leader - Pharma Leader Company (60% Telework)

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.
Advance metrics and the setting of goals that provide visibility and understanding of development effectiveness from a quality perspective.
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.




Engineer, computer Science or other Technical degree, or equivalent work experience.
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.
Additional skills: 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).
Strong interpersonal skills with a proven ability to collaborate across teams and communicate effectively with stakeholders.
Flexibility and adaptability to a fast
changing environment/methodology.
Good level of Technical and Conversational English.

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