Summary

The Supplier Quality Engineer (SQE) ensures that the supply chain companies continually develop their process in line with the design intent of the customer and verify their systems to ensure they are compliant with the end customer's needs. This includes on‑going supply chain company verification. The SQE is responsible for delivering all aspects of the Supplier Quality Assurance function. The SQE collects root cause analysis and provides corrective feedback to prevent line stops due to supply issues. In addition the SQE manages the customer specific requirements and offers technical support to suppliers. The SQE is responsible for ensuring that the products produced meet quality standards required to minimize quality costs and maximize customer satisfaction whilst ensuring that procedures and processes are adhered to.

General Responsibilities

Ensure that specifications cite critical characteristics and required process controls
Provide technical development of the supplier throughout the product development process to assure launch readiness, including development and approval of supplier control plans (process validation requirements, sampling requirements)
Establish incoming inspection plans for components with the supplier & LivaNova R&D department, assemblies and/or finished devices and quality department
Assure the suppliers understanding of LivaNova products, their intended use, and regulatory requirements
Ensure the proper risk controls are implemented at both supplier and LivaNova
Ensure the measurement system at supplier & LivaNova are identical, and/or capable
Monitor and analyze supplier data internally and externally gathered to identify trends and prevent potential problems
Manage the Control and Manufacturing Process Change with the suppliers
Initiate and manage Supplier Corrective Actions (SCAR) in partnership with Manufacturing/Process Engineering and Quality Engineering to ensure complete and effective root cause analysis and corrective action implementation is performed promptly
Proactively identify and help implement improvement to supplier quality and supplier quality tools and processes
Collaborate with other members of the supply team to establish and maintain a meaningful supplier quality scorecard which is part of a bigger supplier scorecard that includes delivery, cost, partnership, etc.
Manage the supplier quality audit process, which includes establishing requirements, setting priorities, determining audit frequency, and performing audits in a lead auditor role

Travel Requirements

25%

Skills and Experience

Qualified Engineer or successfully completed University diploma with several years of industrial experience in manufacturing processes, or an equivalent education
Knowledge of FDA, GMP, ISO 13485 and ISO 9001
Ability to negotiate "win-win" situations with internal customers and external suppliers that meet LivaNova's business needs
Ability to work in a highly matrixed and geographically diverse business environment
Work with the Engineering (Design and Manufacturing Engineers) team to define process parameters and criteria to ensure supplier process capability is effective to meet product and process requirement
Participate in cross‑functional teams in the development of new products or changes related to current products in meeting customer requirements
Advanced computer skills, including statistical/data analysis and report writing skills (Minitab knowledge appreciated)
Good knowledge of Good Manufacturing Practices
Fluent in English (written and spoken)
Basic knowledge of preferred techniques for continuous improvement such as Lean, Six‑Sigma, Poka‑Yoke (Error Proofing), Measurement System Analysis, and Process Failure Mode and Effects Analysis (PFMEA)
Some years of experience in quality area
Availability to travel to suppliers autonomously and able to integrate the different cultures
Nice to have: ISO 9001 and/or 13485 auditor qualification

Benefits

A dynamic role in an advanced Medical Device environment interfacing with all worldwide regulatory landscapes supporting your professional career growth
Exposure to a State‑of‑the‑Art medical device development process, in close co‑operation with international clinicians
Competitive base salary
Variable short‑term & long‑term incentives
Recognition through our STARS Program, we recognize and celebrate our colleagues’ contributions and achievements

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LivaNova, PLC