Design Quality Engineer – Systems

This role will be responsible for ensuring the new products and design changes to existing products meet regulatory and quality requirements throughout the design and development process. This will be accomplished through collaboration with cross-functional teams performing verification and validation, process development activities, product risk management requirements and product reliability activities as it relates to Software and Hardware products.

Your Responsibilities Include

• Lead and support new product development design control deliverables for Software/Hardware products.
• Lead Risk management activities including FMEAs, hazard analysis and other risk management file documents
• Maintains and audits Design History Files.
• Support Process/Design Validation/Verification activities including IQ/CQ/MSA/OQ/PQ activities.
• Provide quality and compliance support during regulatory audits and r...