Manufacturing responsibilities include:

• Oversee product quality during all stages of production and field service.

• Ensure compliance with Good Manufacturing Practices (GMP) regulations and internal quality management systems throughout the manufacturing process.

• Lead and support investigations into nonconforming materials and products (NCRs), working closely with cross-functional teams including Manufacturing and Engineering, identifying root causes, ensuring timely resolution, and implementing effective corrective and preventive actions (CAPAs) to prevent recurrence.

• Conduct Material Review Board and participate in materials decision making.

• Establish, implement, and support processes for field service and rework of robotic medical devices.

• Maintain Device History Records for robotic medical devices

• Support creation of risk management files, including the development of Process FMEA

• Lead and support process validation activities, including IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification), for new and existing manufacturing processes.

• Develop validation protocols, execute validation activities, and compile validation reports to ensure process robustness and consistency.

• Collaborate with cross-functional teams, including Manufacturing and Engineering, to resolve quality issues and identify opportunities for process improvement and efficiency gains within the manufacturing environment.

• Perform audits of manufacturing processes, including inspections, testing, and documentation, to identify areas for improvement and ensure adherence to quality standards.

• Implement Lean and Six Sigma principles to drive continuous improvement initiatives.

Testing responsibilities include:

• Collaborate with cross-functional teams to ensure that design, manufacturing, and standards-based test requirements are met.

• Provide guidance on processes and validations to ensure product safety and compliance.

Packaging and Finished Goods Release responsibilities include:

• 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.

Documentation and Compliance responsibilities include:

• 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.