Overview

The Sr. Quality Assurance Engineer shall provide leadership and support for QMS performance in many facets of business operations:

Design Control

In this role, you will ensure that product development teams consistently apply solid critical thinking throughout the design and development process while maintaining deep expertise in Design Controls, Risk Management, Electrical Safety, and Usability Engineering. You will be responsible for ensuring all design-related activities are properly executed, accurately documented, and fully compliant with internal procedures and global regulatory expectations. You will review Engineering Change Orders (ECOs) and proposed design modifications to confirm they reflect sound engineering practices and uphold device safety and effectiveness. You will also oversee the efficient progression of design changes, ensuring all documentation is complete, traceable, and compliant. As an active participant in cross-functional design reviews, you will evaluate Design and Development Plans, Design Inputs and Outputs,



verification and validation documentation, and design changes. Additionally, you will identify potential safety or performance risks and support appropriate risk management activities. Throughout the process, you will ensure that all design decisions are well justified, thoroughly documented, and aligned with regulatory and quality expectations.

Risk Management

you will actively participate in risk management activities in alignment with ISO 14971, supporting hazard analyses, FMEAs, and the creation and maintenance of all related risk management documentation. You will ensure that risk control measures are properly implemented, thoroughly verified, and supported by objective evidence. You will apply structured, risk‑based decision‑making to ensure product safety and regulatory compliance, while also ensuring that all risk–benefit evaluations are clear, comprehensive, and aligned with global regulatory expectations.

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📌 Senior Quality Assurance Engineer (Hyderabad)
🏢 Spacelabs Healthcare
📍 Hyderabad