Flex
Flex is a global company specializing in design, engineering, and manufacturing services across a wide range of industries. They provide end-to-end lifecycle solutions that address power, heat, and scalability challenges, particularly in data centers. Flex integrates advanced manufacturing, supply chain solutions, and product-enabling technologies to drive efficiencies and sustainability. With a global network, Flex supports innovation in areas such as automotive, healthcare, and cloud communications, delivering value beyond traditional electronic manufacturing services. Flex's commitment to sustainability is evident in their comprehensive solutions and sustainability strategy geared towards 2030 goals.
design • manufacturing • logistics • value-add services • electronics
Software Validation Engineer - CSV
Yesterday
Flex
Flex is a global company specializing in design, engineering, and manufacturing services across a wide range of industries. They provide end-to-end lifecycle solutions that address power, heat, and scalability challenges, particularly in data centers. Flex integrates advanced manufacturing, supply chain solutions, and product-enabling technologies to drive efficiencies and sustainability. With a global network, Flex supports innovation in areas such as automotive, healthcare, and cloud communications, delivering value beyond traditional electronic manufacturing services. Flex's commitment to sustainability is evident in their comprehensive solutions and sustainability strategy geared towards 2030 goals.
design • manufacturing • logistics • value-add services • electronics
📋 Description
• Flex is the diversified manufacturing partner of choice. • We help market-leading brands design, build, and deliver innovative products. • The role involves executing Medical industries software validations. • Reporting to the Manager, conducting meetings to review investigation findings related to IT systems. • Serve as the SME for CSV, maintaining knowledge in the CSV area of expertise. • Prepare reports for senior management and external regulatory bodies as appropriate.
🎯 Requirements
• 5 - 10 years of experience in Medical/Life Sciences industries software validation and compliance reviews. • Strong working knowledge of applied statistics, quality systems, and regulatory requirements across multiple health authorities including 21 CFR 820, 21 CFR Part 11, ISO 14971, ISO 13485, FDA, EU Medical Device Regulation, GAMP, GPSV, and CSV/CSA • High-level strategic problem-solving and reasoning skills. • Analyzes evaluates and presents information concerning findings, trends with IT in business, and development. • Ensure adherence to software validation processes and perform review & approval for all the software validation activities. • Suggests and debates to implement the right SDLC, software validation methods, and procedures with the Flex.
🏖️ Benefits
• Health Insurance • PTO • NK99
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