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Indegene
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Senior Design Quality Engineer

Senior Design Quality Engineer

Indegene

3 - 7 years

0 Lacs

karnataka

Posted:5 days ago| Platform: Shine logo

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Skills Required

risk management fmea rca compliance usability reliability performance security serviceability sustainability software development hardware development verification validation requirements management design usability fault tree analysis leadership project management quality plan development design for reliability vv postmarket analysis supportability manufacturability localizability privacy costs sample size determination statistical methods safety risk management failure modes effects analysis quality system development audit process quality programs implementation crossfunctional collaboration problemsolving verbal written communication decisionmaking attention to detail

Work Mode

On-site

Job Type

Full Time

Job Description

You are a technology-led healthcare solutions provider driven by the purpose of enabling healthcare organizations to be future-ready. At Indegene, you offer accelerated global growth opportunities for bold, industrious, and nimble talent. Your unique career experience celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. If you are looking to explore exciting opportunities at the convergence of healthcare and technology, visit www.careers.indegene.com to kickstart your career. The first few years of your career are crucial as they lay the foundation for your professional journey. Indegene promises a differentiated career experience where you will work at the intersection of healthcare and technology and be mentored by industry experts. You will have the opportunity for global fast-track career growth alongside Indegene's high-speed expansion. As a purpose-driven organization, you focus on enabling healthcare organizations to be future-ready with customer obsession as your driving force. You are bold in actions, nimble in decision-making, and industrious in your work approach. About Indegene - https://www.indegene.com/ Experienced Senior Design Quality Engineer is sought with a focus on ensuring product quality throughout the lifecycle. This includes leading Quality Plan development, validating critical design inputs, ensuring compliance during design reviews, verification, validation, and transfer. The ideal candidate should excel in risk management, design for reliability (FMEA, V&V, RCA), and post-market analysis to drive continuous improvement. Collaboration across functions to deliver high-quality, customer-focused, and regulatory-compliant products is essential. Roles and responsibilities: - Develop appropriate quality plans covering all product lifecycle stages - Provide oversight of Quality Plan execution, Risk Management activities, and design-related tasks - Validate key design inputs such as usability, reliability, performance, and more - Assess product quality performance and conduct post-market analysis - Ensure compliance during design reviews, verification, validation, and transfer - Apply design for quality and reliability best practices Skills: - Knowledge of global medical device or consumer product regulations and standards - Experience in Software or Hardware development, Verification and Validation, Risk management, RCA, and more - Familiarity with Sample Size Determination, Statistical Methods, Safety Risk Management, and Failure Modes and Effects Analysis - Understanding of quality system development, documentation, and implementation - Ability to develop and implement quality programs, including problem-solving Qualifications: - Bachelor's degree in Engineering - Minimum 3 years of experience in medical device-related Quality & Regulatory domain with knowledge of design control principles EQUAL OPPORTUNITY Apply now if you are excited about this opportunity to contribute to the future of healthcare technology!,

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Senior Design Quality Engineer