Title: Instrumentation Quality Engineer

Summary:

• In this role, you will work closely with R&D, Regulatory, and other cross-functional design and development stakeholders to provide hands-on quality engineering support across the product development lifecycle.
• You will contribute to key activities such as design controls, risk management, verification and validation, supplier-related quality support, change control, and product transfer.
• The ideal candidate brings strong technical judgment, knowledge of design and development processes, demonstrated quality capability, and the ability to operate independently in a fast-paced environment.

Major Accountabilities:

• Provide hands-on quality engineering support for new product development projects and design changes to existing instrumentation products.
• Ensure quality requirements are appropriately applied throughout development, documentation, verification, validation, and transfer activities.
• Partner with design and development project teams to provide practical quality guidance, technical assessment, and risk-based decision support that helps keep development activities moving forward.
• Review and approve design control deliverables, including risk management files, verification and validation documentation, and related development records.
• Evaluate product and process changes for quality and regulatory impact, and support change control activities from assessment through implementation.
• Partner with cross-functional teams to investigate deviations, support root cause analysis, and drive corrective and preventive actions as needed.
• Maintain compliance with applicable GxP requirements, standard operating procedures, and documentation practices.