Job Function: Engineering

Job Family: Quality Assurance Engineering

Business Label: Design

Reports to: Manager, Product Quality (India)

Location: Bangalore, India

Working Type: Hybrid

At ASP, we believe in you. We believe in your potential - your ability to learn, grow, and contribute in meaningful ways. We believe in the power of excellent people working together to innovate and solve problems no one could solve alone. We build enduring partnerships with our customers and take on their challenges and opportunities as our own.

Job Summary

Provides design quality engineering guidance and support for New Product Introduction (NPI) and/or Product Life Cycle Management (LCM) activities, with a focus on product quality while ensuring compliance to company-wide Quality Management System and regulatory requirements for life science products (electro-mechanical devices, software, hardware, biocides, detergents, biological and chemical indicators). Provides specific quality engineering support to New Product Development, Quality improvements, Design Verification and Validation,



Design Control, and Risk Management processes. This includes ownership of risk management deliverables, the pathway from field signals to design inputs and their tracked implementation, for both internally and externally designed products. Applies in-depth knowledge of quality engineering principles, relevant regulations, standards, industry best practices, and other related disciplines to assignments. Independently plans and executes complex projects and assignments within broad guidelines, exercising judgment based on analysis of multiple sources of information. Receives minimal guidance and acts as a resource for colleagues with less experience.

Key Responsibilities

• Owns the Risk Management process and deliverables (hazard analysis, DFMEA/SWFMEA, software hazard analysis, risk control verification, and the Risk Management File/Report per ISO 14971), collaborating with representatives from o

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