What will you be doing?

• Serve as the Design Quality representative for product support and lifecycle management activities, including product improvements, design changes, quality planning, investigations, and continuous quality enhancement initiatives
• Lead risk management activities including risk assessments, FMEA development and maintenance, implementation of risk controls, risk reviews, and verification of effectiveness
• Provide design quality oversight and approval for design verification and validation activities, sterilization validations, process validations, supplier qualifications, manufacturing process changes, and test methods
• Lead or support investigations related to complaints, nonconformances, CAPAs, post market surveillance, trend analysis, and product risk assessments to identify root causes and drive corrective and preventive actions
• Review and approve quality and engineering documentation to ensure compliance with design controls, change control, risk management, and quality system requirements
• Partner closely with Regulatory Affairs, Operations, R&D, Manufacturing, Marketing, Clinical, and Supplier Quality teams to support regulatory submissions, audits, inspections, and ongoing product support
• Act as a quality engineering resource for complex technical and compliance related issues, providing guidance and influencing decisions that impact product quality, patient safety, and business objectives
• Identify and drive continuous improvement opportunities through analysis of quality data, product feedback, risk management outputs, and operational performance metrics
• Provide technical leadership, training, guidance, and mentorship to support effective decision making, accountability, compliance, and quality excellence

What will you need to be successful?

• Bachelor of Science degree in Engineering or a technically related field
• 5+ years of experience in the medical device industry or another highly regulated environment
• Strong knowledge of FDA QSR, ISO 13485, and ISO 14971 requirements
• Experience with risk management, design controls, change control, CAPA, validation activities, and product lifecycle management
• Demonstrated ability to solve complex quality challenges and influence cross functional stakeholders
• Excellent communication, collaboration, and problem solving skills
• CQE and/or Six Sigma certification preferred

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