Supplier Quality Engineer

Overview

Team Based, Supportive Environment

As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you re looking for a new chance, a new beginning, a new trajectory, Liva Nova is where your talent can truly thrive.

Join our talented team members worldwide to become a pioneer of tomorrow—because at Liva Nova, we don’t just treat conditions — we aspire to alter the course of lives.

Liva Nova is a global medical technology company built on nearly five decades of experience and a relentless commitment to improving the lives of patients around the world. Our advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems. The company is listed on the NASDAQ stock exchange under the ticker symbol “ LIVN .”

Liva Nova is headquartered in London (UK) with a presence in over 100 countries and a team of more than 3,000 employees worldwide.

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.

Functional Responsibilities Of This Position Include

• 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 with 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;
• Carries out supplier Quality Management System (QMS) and process audits
• Works with the supplier directly, create 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
• Collaborate with operations to support the receiving inspection and process failures and ensure timely support, communication and resolution of issued 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 in 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 develop systems to ensure that parts and services are provided by approved sources
• Performs other duties as may be required by management.

To ensure successful execution of the responsibilities outlined above, a successful contributor will:

• Develop and…