Quality Control and Assurance
• Lead and execute QC processes on the medical device production line, with a focus on in-process monitoring and control
• Implement and oversee in-line quality control processes to inspect products during their journey through the production line
• Create and implement monitoring points throughout the production process
• Conduct methodical investigations into production obstacles, aligning with industry quality standards
• Perform and oversee audits of raw materials intake and final product inspections
• Calibrate all production facilities and maintain calibration schedules
Process Improvement and Documentation
• Lead and execute ongoing production improvement initiatives
• Identify inefficiencies or deviations in production workflows, using tools like scatter charts or fishbone diagrams
• Write detailed internal reports on quality metrics, trends, and corrective actions
• Develop and update work procedures for various production stages
• Standardize and centralize quality data from production processes
Subcontractor Quality Management
• Conduct audits of critical subcontractors to verify compliance with ISO 13485 and other regulatory requirements
• Perform thorough inspections of raw materials and subassemblies at subcontractor sites
• Apply risk-based approaches to assess subcontractor processes
• Work closely with subcontractors to address non-conformities and implement corrective actions
Team Leadership and Collaboration
• Directly manage and mentor the QC team, fostering a culture of excellence
• Work closely with multiple departments including production, R&D, operations, and external subcontractors
• Conduct and participate in internal and external audits