Software Quality Assurance Specialist Ii
hace 3 días
At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's 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 processes across 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 on global regulations and standards, including ISO 13485, FDA 21 CFR Part 11, Part 820.- Provide support during regulatory 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 in periodic reviews of GxP systems and conduct risk assessments and impact analyses for 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 the global 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 with Jabil CSV procedures and associated work instructions.- Maintain the Master System Inventory, ensuring accurate tracking of all GxP systems.- Ensure compliance with the company’s security 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.**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.****Accessibility Accommodation**:whereyoubelong
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Software Quality Assurance Specialist II
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Chihuahua, México jobr.pro A tiempo completoAt Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's 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...
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Software Quality Assurance Specialist II
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Chihuahua, México jobr.pro A tiempo completoAt Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's 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...
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Software Quality Assurance Specialist II
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QA & CSV Lead for Regulated Healthcare Systems
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Chihuahua, México jobr.pro A tiempo completoA leading global manufacturing solutions company is seeking a Software Quality Assurance Specialist II in Chihuahua, Mexico. This role is essential for ensuring that healthcare systems comply with regulatory requirements such as ISO 13485 and FDA 21 CFR standards. Responsibilities include standardizing processes, mentoring staff, facilitating audits, and...
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QA & CSV Lead for Regulated Healthcare Systems
hace 4 semanas
Chihuahua, México jobr.pro A tiempo completoA leading global manufacturing solutions company is seeking a Software Quality Assurance Specialist II in Chihuahua, Mexico. This role is essential for ensuring that healthcare systems comply with regulatory requirements such as ISO 13485 and FDA 21 CFR standards. Responsibilities include standardizing processes, mentoring staff, facilitating audits, and...
