Supplier Quality Engineer

Job Opportunity at Liva Nova

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.

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.
• 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 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 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.

Experience working in a regulated environment industry such as a 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: capable to prioritize and plan activities with specific attention to understand expectations of internal personnel and external stakeholders.

Good team player: open and honest when communicating among peers and management. Resolves most…