Senior Supplier Quality Engineer

The Senior Supplier Quality Engineer 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. Location & Travel This position is available as a Remote opportunity or as a hybrid role based at our site in Clear Lake, TX (Southeast Houston area). It may require business travel up to 25% of the time. Job Duties Lead the supplier selection, evaluation and approval process by assessing manufacturing/technology capabilities, supplier risk levels and Quality Management System compliance. Serve as a core team member on component development teams by providing technical leadership and direction. Responsible for supplier process qualification, verification and validation activities. Review supplier process changes for completeness, accuracy, safety and effectiveness, and manage these changes to ensure continued supply of parts. Act as the business process owner for all supplier related nonconformance report (NCR) management, including Material Review Board activities and monitoring their timeliness and effectiveness. Carry out supplier QMS and process audits. Collaborate with suppliers on process improvement, validation (TMV, IQ, OQ, PQ) and value enhancement opportunities. Ensure ongoing compliance with ISO 13485 and MDSAP requirements. Collaborate with Purchasing and procurement functions to support business strategy initiatives such as cost saving, alternate sourcing and outsourced processes. Provide quality criteria (risk assessment, acceptance criteria, sample size, parameter definition) for receiving inspection activities. Ensure procedures and processes are updated and consistent with regulatory changes, including development of more efficient QMS processes. Compile and present quality data to management and in management review. Contribute to regulatory audits by coordinating back‑room/front‑room activities or serving as a subject‑matter expert. Support enterprise resource planning controls and develop systems to ensure parts and services are provided by approved sources. Perform other duties as required by management. Minimum Qualifications Bachelor's Degree in Engineering. 8+ years of Quality or Manufacturing Engineering experience in a regulated environment such as a FDA medical device manufacturer. Understanding of basic quality engineering principles—including quality leadership, implementation, acceptance sampling, statistical process control, lean business systems, continuous improvement techniques, and risk management. Pragmatic, result‑oriented, capable of prioritizing and planning activities with attention to expectations of internal and external stakeholders. Good team player who communicates openly and honestly with peers and management and knows when to escalate issues. Project management skills with the ability to drive cross‑functional teams to project completion within planned timeframes. Strong interpersonal skills. Record of performance demonstrating metrics meeting objectives during tenure in previous positions. Pay Transparency The annual base salary is estimated at $110,000–120,000 plus discretionary annual bonus. Pay ranges may vary by location and are awarded based on experience. Benefits Health benefits – Medical, Dental, Vision Personal and vacation time Retirement & savings plan (401(k)) Employee stock purchase plan Training & education assistance Bonus referral program Service awards Employee recognition program Flexible work schedules #J-18808-Ljbffr LivaNova PLC