Work Flexibility: Hybrid
What you will do:
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Risk Management, Design Inputs review, Design History File Document review, Design Output Document review, V&V protocols and reports review, Review and approval of ECO/ECR.
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Effective change control for NPD and Sustaining Products.
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Participate in Risk Management per ISO14971 to ensure the safety and effectiveness of product.
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Participate in design reviews during various phases of NPD.
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Work with team to develop robust verification, Design validation & release strategies to ensure product compliance, safety, reliability & effectiveness.
What You Will Need:
Required Qualifications
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Bachelor’s in computers/ IT/ Electronics.
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5-7 years of relevant work experience.
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Good understanding of Quality Management Systems. (ISO 13485, 21 CRF 820)
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Experience on NPD process and various phases of new product development.
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Knowledge of ISO 14971, IEC 62304, IEC 62366, 60601-1 family of standards.
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Expert-level knowledge of current industry standards for New Product Development and risk management practices.
Preferred Qualifications:
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Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).
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Strong interpersonal skills, written communication and negotiations skills.
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Good analytical and problem-solving skills.
Travel Percentage: 50%
