LivaNova
medtech
SupplierQualityEngineer(m/f/d)
Neural analysis suggests this role is
optimal for Mid candidates.
“Supplier Quality Engineer (m/f/d) at LivaNova. Skills: Supplier Quality, Quality Assurance, Process Engineering, Auditing. Ensure specifications cite critical characteristics. Provide technical development of supplier”
What You'll Achieve.
Minimize quality costs; Maximize customer satisfaction; Ensure procedures and processes are adhered to; Assure launch readiness; Ensure supplier process capability is effective; Meet product and process requirement; Meet customer requirements
Industry & Context.
Root cause analysis; Corrective feedback; Prevent line stops; Identify trends; Prevent potential problems
Travel Requirements 25 %, Availability to travel to suppliers autonomously
What They're Looking For.
Must Have
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, 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
Minitab knowledges appreciated, ISO 9001 and/or 13485 auditor qualification
What You'll Do.
Ensure specifications cite critical characteristics
Provide technical development of supplier
Establish incoming inspection plans
Assure supplier understanding of products
Ensure proper risk controls are implemented
Ensure measurement systems are identical
Monitor and analyze supplier data
Manage control and manufacturing process change
Initiate and manage Supplier Corrective Actions
Identify and implement improvements to supplier quality
Collaborate to establish supplier quality scorecard
Manage supplier quality audit process
Perform audits in lead auditor role
How You'll Work.
Team & Collaboration
Collaborate with other members of the supply team; Work with the Engineering (Design and Manufacturing Engineers) team; Participate in cross-functional teams
Communication Scope
Fluent in English (written and spoken); Ability to negotiate "win-win" situations
Process & Methodology
Manage the Control and Manufacturing Process Change with the suppliers, Initiate and manage Supplier Corrective Actions (SCAR), Manage the supplier quality audit process
Full Job Description
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, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow—because at LivaNova, **we don’t just treat conditions — we aspire to alter the course of lives.** **Supplier Quality Engineer (m/f/d)** **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
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