Product Quality Engineer - Robot

About the role

The Product Quality Engineer supports quality engineering activities, testing, and packaging validation for robotic devices. This role collaborates across various teams to ensure compliance with regulatory standards and drive continuous improvement.

Responsibilities

• Oversee product quality during all stages of production and field service
• Ensure compliance with Good Manufacturing Practices (GMP) and internal quality management systems
• Lead and support investigations into nonconforming materials and products (NCRs)
• Establish, implement, and support processes for field service and rework of robotic medical devices
• Maintain Device History Records for robotic medical devices
• Develop validation protocols and execute validation activities
• Collaborate with cross-functional teams to resolve quality issues and identify process improvement opportunities
• Perform audits of manufacturing processes, including inspections, testing, and documentation
• Implement Lean and Six Sigma principles to drive continuous improvement initiatives
• Collaborate with cross-functional teams to ensure design, manufacturing, and standards-based test requirements are met
• Provide guidance on processes and validations to ensure product safety and compliance
• Oversee packaging validation activities to ensure product integrity and stability during storage and transportation
• Participate in finished goods release processes, ensuring compliance with release criteria and applicable regulatory requirements
• Maintain accurate and up-to-date documentation related to quality control processes, inspection results, metrology records, nonconformance reports, and corrective actions
• Ensure compliance with relevant regulatory requirements, such as FDA QSR and ISO 13485 standards
• Support internal and external audits, including preparation of documentation, participation in audits, and implementation of audit findings

Requirements

• Bachelor's degree in Engineering or a related technical field
• Master's degree is a plus
• Minimum of 5 years of experience in a manufacturing quality engineering role within the medical device industry supporting electromechanical capital devices
• In-depth knowledge of FDA regulations, ISO 13485, IEC 60601-1, and other relevant quality & safety standards for robotic medical devices
• Experience with nonconforming material investigations and implementing effective CAPAs
• Ability to work in a fast-paced environment

Qualifications

• Experience supporting development and manufacturing of surgical robotic devices
• Certifications such as Six Sigma and ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA)
• Familiarity with process validation (IQ/OQ/PQ), electrical safety testing, and packaging requirements for medical devices
• Strong understanding of GMP regulations and quality management systems
• Excellent problem-solving skills and ability to apply root cause analysis methodologies
• Detail-oriented with effective organizational and documentation skills
• Strong communication and collaboration skills to work cross-functionally and interact with technicians, engineers, auditors, and third parties
• Attention to detail, with a focus on accuracy and precision in quality-related activities

Benefits

• Medical, dental, and vision coverage at 100%
• Flexible work hours
• Fun office environment with bike-friendly and running shoe options