Senior Product Quality Engineer

About the role

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).

What you'll do

• Owns the Risk Management process and deliverables (hazard analysis, DFMEA/SWFMEA, software hazard analysis, risk control verification
• Owns the complaint-to-design-input pathway as the Design Quality liaison between Customer Quality and Design Engineering to ensure field signals (complaint trends
• Performs complex technical investigations including formal NCs and CAPAs coordinating cross-functionally to ensure sound experimental design
• Acts as a resource for colleagues in risk management, design control, verification and validation, or CAPA and supports new product introduction, design changes
• Provides training and informal guidance on quality management system elements to colleagues with less experience and representatives from other functional areas

What you need

• 5–8 yrs of experience
• Excel
• PowerPoint
• FMEA
• Quality control
• Lean
• B.Tech or B.E.

Good to have

• Biology
• Microbiology
• Chemistry
• Bug tracking
• JIRA