Supplier Quality Engineer

Position Summary

This position functions as the technical liaison between internal resources (Purchasing, R&D, Operations, QE) and suppliers to implement and monitor advanced quality planning in the procurement process for new product introductions and throughout the product life cycle, identifying and developing cost‑effective technical solutions that resolve issues related to product quality, consistent supply and yield, and developing approaches to improve quality and reduce cost.

• Leads the supplier selection, evaluation and approval process by assessing manufacturing/technology capabilities, supplier risk levels, Quality Management System compliance, etc.
• Serves as a core team member on component development teams by providing technical leadership and direction. Responsible for supplier process qualification, verification and validation activities.
• Reviews supplier process changes for completeness, accuracy, and safety/effectiveness including the identification of all impacts and timely management of these changes to ensure continued supply of parts.
• Acts as business process owner for all supplier‑related nonconformance report (NCR) management system, including material review board (MRB) activities, monitoring the timeliness and effectiveness of the system and activities.
• Carrying out supplier Quality Management System (QMS) and process audits.
• Works with suppliers directly, creates corrective action plans to address process failures following the nonconforming product control and CAPA process.
• Collaborates with suppliers on process manufacturing process improvement, process validation (TMV, IQ, OQ and PQ) and value enhancement opportunities.
• Ensures ongoing compliance per ISO
  13485 and MDSAP requirements.
• Collaborates with operations to support receiving inspection and process failures and ensures timely support, communication and resolution of issues related to supplied parts.
• Collaborates with Purchasing and procurement functions to support business strategy initiatives including cost‑saving efforts, alternate sourcing, outsourced processes, etc.
• Provides quality criteria (risk assessment, acceptance criteria, sample size, parameter definition) for receiving inspection activities.
• Ensures that procedures and processes are maintained and updated to be consistent with regulatory changes, including the development of more efficient QMS processes and global QMS processes.
• Compiles and presents quality data to management as requested and during management review.
• Contributes to successful regulatory audits by coordinating back‑room / front‑room activities or serving as a subject‑matter expert.
• Supports enterprise resource planning controls and develops systems to ensure that parts and services are provided by approved sources.
• Performs other duties as may be required by management.

• Develop and maintain strong, positive business relationships with key internal customers such as Purchasing, Operations, R&D, Project Management Office (PMO), Clinical, Regulatory Affairs (as appropriate) to fulfill the requirements of supplier management activities.
• Gain a full understanding of Liva Nova devices, how they are designed and manufactured, how they function, and how they deliver clinical benefit to determine how supplied components and services impact device functioning.
• Maintain and improve technical knowledge in the area of expertise to provide value‑added feedback for supplier management process development, investigations, and product/process changes to ensure the safety and effectiveness of Liva Nova devices.
• Collaborate with other areas to achieve supplier management objectives.

• Experience working in a regulated environment such as an FDA medical device manufacturer.
• Technical education and experience in an area relevant to Liva Nova devices.
• Understanding of basic quality engineering principles including, but not limited to: quality leadership, implementation, acceptance sampling, statistical process control, lean business systems and other continuous improvement techniques, and risk management.
• Pragmatic and result‑oriented:…