Supplier Quality Engineering Manager – Supplier Controls

Job description

**General Summary** We are seeking a Supplier Quality Engineering Manager to help manage our Supplier Controls. This position is responsible for the effective execution, oversight, and continuous improvement of supplier quality processes and controls that support manufacturing operations and regulatory compliance. The manager will own key supplier quality processes, including Approved Supplier List (ASL) management, supplier onboarding and qualification controls, and supplier performance monitoring. This individual will ensure that established processes are consistently executed, appropriately controlled, and compliant with quality management system requirements while driving improvements that enhance efficiency, standardization, and operational effectiveness. The role will play an important part in modernizing supplier quality processes and systems, leveraging enterprise platforms and cross-functional partnerships to simplify workflows, strengthen controls, and improve how supplier quality activities are managed. The manager will also lead a dedicated team of Supplier Quality Engineers supporting supplier quality operations and the needs of Operational Procurement across multiple manufacturing sites. The successful candidate will bring strong supplier quality engineering fundamentals, practical experience managing quality processes, effective people leadership, and a continuous improvement mindset. **Primary Responsibilities** **Supplier Quality Controls** - Own and manage supplier quality control processes, including ASL maintenance, supplier addition requests, supplier approval status, and associated supplier qualification controls. - Ensure supplier onboarding, approval, and qualification activities are executed consistently, efficiently, and in accordance with established risk-based requirements and quality management system procedures. - Maintain effective governance of supplier quality records, approval workflows, supplier status, and associated documentation to ensure traceability, accuracy, and regulatory compliance. - Establish and maintain standardized processes, clear accountability, and appropriate controls to ensure reliable execution and sustained compliance. - Monitor process effectiveness, address execution gaps, and drive improvements in process adherence, turnaround times, and operational efficiency. **Supplier Quality Process Improvement** - Drive the improvement and modernization of supplier quality processes to enhance efficiency, simplify workflows, strengthen controls, and support evolving business needs. - Improve the utilization and effectiveness of enterprise systems, including SAP, AssurX, TrackWise, and other applicable quality management platforms, to support supplier quality activities. - Partner with Quality Engineering leadership, IT, Quality Systems, and cross-functional stakeholders to identify improvement opportunities, define business requirements, and implement practical, sustainable solutions. - Support the transition of manual supplier quality activities to streamlined, electronically managed processes that maintain appropriate quality system controls and regulatory compliance. - Coordinate process changes, system implementation activities, validation support, and associated QMS documentation updates with appropriate functional stakeholders. - Ensure improvements are effectively implemented, adopted, and sustained through standardized practices, training, and ongoing process monitoring. **Supplier Quality Performance Monitoring** - Manage standardized processes for monitoring, tracking, and reporting supplier quality performance, including supplier nonconformances, corrective actions, supplier changes, and other established quality indicators. - Ensure supplier quality data is accurate, consistent, and accessible to support supplier performance evaluations, trend analysis, and management decision-making. - Collaborate with manufacturing sites to ensure consistent application of supplier quality processes, controls, and performance monitoring practices. - Support supplier quality activities across domestic and international manufacturing locations, including supplier onboarding, supplier-related requests, receiving quality issues, and supplier changes. - Partner with site Quality Engineering, Incoming Quality Control, and Operational Procurement teams to address process inconsistencies and improve cross-site coordination. **Team Leadership** - Lead, coach, and develop a team of Supplier Quality Engineers responsible for supplier controls and assigned operational support activities. - Provide dedicated engineering support for Supplier Change assessments, incoming quality nonconformances, and other supplier quality activities in coordination with Supplier Quality Engineering leadership. - Ensure timely, technically sound, and risk-based execution of assigned supplier quality activities in accordance with established procedures and quality system requirements. - Partner closely with other SQE Managers and Operational Procurement to align priorities, balance resources, and support timely resolution of supplier quality needs. - Establish clear team expectations, develop employee capabilities, and foster a culture of accountability, collaboration, and continuous improvement. **Required Qualifications** - Bachelor's degree in Engineering, Science, or a related technical discipline. - 8+ years of progressive experience in Supplier Quality Engineering, Quality Engineering, or related quality functions within a regulated manufacturing environment. - Strong working knowledge of supplier quality management processes, including supplier qualification, supplier onboarding and approval, supplier controls, supplier performance monitoring, supplier changes, and nonconformance management. - Experience managing or providing technical leadership to quality engineering teams. - Demonstrated ability to manage quality processes, ensure procedural compliance, and drive improvements in operational execution. - Experience working with ERP and/or electronic quality management systems in support of quality processes and controls. - Working knowledge of ISO 13485, FDA Quality Management System Regulation (QMSR), and applicable supplier control requirements. - Strong organizational, analytical, communication, and cross-functional collaboration skills. **Preferred Qualifications** - Supplier Quality Engineering experience in medical device manufacturing. - Experience managing Approved Supplier Lists, supplier qualification records, supplier approval workflows, and related QMS processes. - Experience with SAP, AssurX, TrackWise, MasterControl, or comparable enterprise and quality management systems. - Experience improving quality workflows, defining business requirements, and supporting electronic system enhancements and implementation. - Experience establishing or maintaining supplier performance metrics, scorecards, and quality reporting. - Experience supporting supplier quality activities across multiple manufacturing locations. - Demonstrated success improving quality process efficiency, standardization, and execution. - ASQ certification, Lean Six Sigma certification, or relevant continuous improvement training. **Leadership Expectations** The Supplier Controls Manager is expected to demonstrate strong ownership of supplier quality processes, ensuring they are effectively executed, appropriately controlled, and continuously improved. This individual should possess the technical judgment to evaluate supplier quality risks, the operational discipline to maintain reliable and compliant processes, and the initiative to improve and modernize established ways of working. Success in this role requires balancing daily supplier quality responsibilities with process improvement, effective cross-functional collaboration, employee development, and support for manufacturing operations. **Location and Salary** - **Location:** Alameda, CA - **Annual Base Salary Range:** $145,000 to $214,000 - We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. **Working Conditions** - General office, laboratory, and cleanroom environments - Willingness and ability to work on site. May have business travel from 0% - 25% - Potential exposure to blood-borne pathogens - Requires some lifting and moving of up to 25 pounds - Must be able to move between buildings and floors. - Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. - Must be able to read, prepare emails, and produce documents and spreadsheets. - Must be able to move within the office and access file cabinets or supplies, as needed. - Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.