At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the worlds top brands offering comprehensive engineering manufacturing and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.

Software Quality Assurance Specialist II is responsible for ensuring that all computerized systems used in healthcare operations comply with regulatory requirements such as FDA 21 CFR Parts 11 and 820 and ISO 13485. This role is critical in maintaining data integrity patient safety and product quality through rigorous validation of software and systems.

• Involved in standardization of CSV processesacross all sites in accordance with global regional and site-level directives.

• Coach and mentor CSV engineers and other project personnel on procedures forms templates and regulatory requirements fostering a culture of compliance and continuous improvement.

• Knowledge onglobal regulations and standards including ISO 13485 FDA 21 CFR Part 11 Part 820.

• Provide support duringregulatory audits and inspections ensuring readiness and robust documentation.

• Lead the overall test effort by defining the testing strategy.

• Author and approve validation deliverables (e.g. validation plans and validation summary reports).

• Participate inperiodic reviewsof GxP systems and conductrisk assessments and impact analysesfor both new and existing systems

• Design and deliver training programs in a variety of formats focused on regulatory compliance quality systems and validation practices. Ensure all personnel involved in the Computer System Validation (CSV) process are appropriately trained and their training status is up to date.

• Assist the Supplier Quality function as SME in supplier assessments as necessary.

• Report key CSV metrics to theglobal metrics team contributing to enterprise-wide performance tracking.

• Collaborate with cross-functional teams (QA IT Manufacturing R&D) to define system / business requirements analysis and validation strategies.

• Ensure all validation activities are conducted in accordance withJabil CSV proceduresand associated work instructions.

• Maintain theMaster System Inventory ensuring accurate tracking of all GxP systems.

• Ensure compliance with the companyssecurity policies and procedures.

• Perform additional duties and responsibilities as assigned contributing to the overall success of the CSV program.

• Review and conduct requirements traceability to design specifications.

• Supervise and lead test development dry-running execution and post-execution review.

TEN CUIDADO CON LOS FRAUDES: Las oportunidades laborales legítimas en Jabil se pueden encontrar en nuestro sitio web oficial . Ningun solicitante debe pagar para acceder a estas oportunidades de empleo. Al postularte para un empleo en Jabil serás contactado a través del portal oficial de jabil por un correo electrónico con teminacion @; llamada telefónica directa de un integrante del equipo de Jabil; o correo electrónico directo con una dirección de correo electrónico @. Jabil no solicita pagos para realizar entrevistas ni en ningún otro momento durante el proceso de contratación. Jabil tampoco pedirá información personal de identificación como número de seguro social acta de nacimiento información de institución financiera número de licencia de conducir o información de pasaporte por teléfono o correo electrónico. Si crees que estás siendo víctima de robo de identidad o fraude repórtalo a la policía en los siguientes números y repórtala en el sitio web donde la encontraste. Llama a: 911 o 089.

Jabil including its subsidiaries is an equal opportunity employer and considers qualified applicants for employment without regard to race color religion national origin sex sexual orientation gender identity age disability genetic information veteran status or any other characteristic protected by law.

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