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6 hours ago
In this role, you will have the opportunity to establish and lead Design Quality Control, Assurance, and Regulatory Affairs teams within a regulated industry.
The ideal candidate will have experience in developing and implementing quality management systems for medical devices, ensuring regulatory compliance with relevant standards and regulations.
Key Responsibilities:- Develop and implement quality management systems for medical devices.
- Ensure regulatory compliance with relevant standards and regulations (e.g. CDSCO, FDA, MDSAP).
- Lead/contribute to Electrical & Electronics technical solutions and products.
- Design, analyze, integrate and document products, systems or subsystems.
- Provide technical guidance and oversight to include concept development and peer/design review participation.
- Minimum of Bachelor's Degree in relevant field (Engineering, Physics, etc.).
- Experience in understanding and interpretations of Risk Management, Design Controls, Standards & Regulations, CDSCO, FDA, MDSAP, etc for Class 2 and Class 3 devices.
- Ability to effectively communicate technical information in English (both written and oral).
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