Instrumentation Quality Engineer

Roles & Responsibilities

• 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 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

Education & Experience

• Bachelor's degree in engineering, life sciences, or a related technical field
• 2+ years of quality engineering experience in the medical device industry, including direct support of instrumentation or electromechanical product development in an ISO 13485 environment
• Experience with design controls, change control, and product impact assessments
• Working knowledge of applicable medical device quality system and regulatory requirements, including ISO 13485, design controls and GxP principles
• Ability to work effectively across global, cross-functional teams, communicate clearly with technical and non-technical stakeholders, and contribute with minimal ramp-up
• Experience with risk management in accordance with ISO 14971
• Experience reviewing or supporting verification and validation protocols, reports, and related documentation
• Statistical knowledge to support sample size determination and the design of verification and validation studies
• Working knowledge of applicable product and safety standards, such as the IEC 60601 series and ISO 14971
• ASQ Certified Quality Engineer (CQE) certification
• Six Sigma Green Belt or higher
• Strong communication, organization, collaboration, and independent problem-solving skills