"Manager Global Custom Quality"

The Manager Global Custom Quality at Starkey Laboratories, Inc. is responsible for ensuring the quality of manufacturing processes, the final product, and adherence to global regulatory requirements. This role involves ensuring that customer requirements are met and that products meet specifications while reducing the Cost of Poor Quality. The manager will evaluate and develop talent to utilize standard problem-solving methods and tools to reduce defects and improve process capabilities. Additionally, the position includes conducting Quality/Six Sigma training and coaching local teams to eliminate defects. The manager will be involved in quality planning and local execution to transform the organization into a quality prevention and assurance mindset. They will assure the linkage of Customer Requirements to Product Specifications, Component Critical Features, and specifications, as well as Process Control plans. The role also requires coordinating the review and updates to Process FMEA's to ensure risks have been identified and mitigated, defining capable measurement systems with adequate GR&R for all specifications, and collecting data to make improvements that reduce customer complaints and enhance internal processes and supplier quality. Collaboration with Customer Quality, Sales, Marketing, Engineering, Sourcing, and Supply Chain is essential to ensure customer requirements are met. The manager will monitor and report quality performance KPIs for the custom product line and coordinate with management to assure compliance with Global Quality System requirements and maintain ISO 13485 certification. Organizational improvement and communication with customers and external Regulatory Agencies are also key responsibilities.