Sr Manager Quality Engineering

The Sr. Manager Quality Engineering is responsible for supporting all quality engineering activities to support the new product life cycle, from concept to commercialization, and sustaining activities. The Quality Engineering function serves as the main quality contact and is a key member of the cross-functional development and sustaining teams. The role serves as the key resource for ensuring compliance to applicable regulatory requirements and quality management system processes. Key Duties and Responsibilities: Foster and sustain a culture of quality that prioritizes patient safety, product reliability, and regulatory compliance. Partner with cross-functional teams to ensure quality is embedded in all aspects of product development and manufacturing, enabling our customers to confidently care for the patients who depend on our products. Supports and provides direction to product development teams for the required quality deliverables. Manage quality resource allocation and workload to support assigned projects. Ensures that product design meets customer expectations, regulatory requirements, appropriate voluntary standards, and all corporate requirements. Shows focus toward continuous improvement. Review, assess, and approve product design documentation to ensure compliance throughout product development cycle. Review and approve engineering designs/changes for adequate quality, reliability, maintainability, risk management, modeling, systems design, assessment tools, reporting, and manufacturability. Write, review, and approve design verification and design validation protocols and reports. Ensure design activities prove design inputs and user needs are adequately addressed. Troubleshoot and direct the resolution of quality issues by fostering effective interdepartmental and cross-functional partnerships. Act as a mentor for employees. Be the first level resource for employees and encourage continuous improvement. Ensure application of the risk management process throughout all activities with a focus on clinician and patient safety. Support product development through capability assessment, analyzing performance data, facilitating problem-solving activities, developing quality tools, and quality techniques. Support sustaining activities such as complaint investigation and complaint trending. Monitor and analyze manufacturing and service trends. Able to perform data mining, analyze data and create trend reports. Investigates process and product issues identified through complaints and trend analysis of other conformance data. Works with other functional groups to resolve difficult quality problems on products, processes, or materials used in manufacturing operations. Direct and facilitate investigations and the corresponding preventative actions and corrective actions that result from abnormal results, customer complaints, quality inquiries, and other quality performance indicators. Support internal audits. Provide support…