Our mission is to strive to create high-tech implantable devices and diagnostic solutions for cardiac diseases, which are accessible to the greatest number of people, while offering valuable services to patients, physicians, hospitals and health care insurers.
The Senior Supplier Quality Engineer (SQE) represents MicroPort in managing the quality relationship with the suppliers, throughout the supplier lifecycle from supplier qualification to the manufacturing and to post market life cycle, by considering the customer specific requirements and offering technical support to ensure the fulfilment of the company objectives in compliance with established standards and regulations (e.g.: FDA 21 CFR Part 820, ISO13485, European Medical Device Directives 90/385/EEC and 93/42/EEC, European MDR 2017/745, Japan PAL and ordinance #169, China regulation, Canada MDR SOR/98-282, TGA and any other applicable regulation).
Work location: Saluggia (VC)
Travel availability: approx. 50%
Your missions will be as follows:
The purpose of the Supplier Quality Engineer role shall be achieved by:
* Ensure Company compliance with the Supplier Management procedure
* Ensure that suppliers provide services respecting applicable regulations and specifications
* Identify and help implement improvement to supplier quality management tools and processes
* Work with the supplier on their understanding of MicroPort CRM products, their intended use, and regulatory requirements
* Supporting MicroPort CRM improvement initiatives related to suppliers (i.e. Purchasing group in Cost Reduction projects)
* Pre-production activities
* Contributing to the selection of suppliers with R&D, Operation and Purchasing department and qualification through audit process
* Collaborating with R&D in the development and communication to suppliers of component specification documentation, review and approve components specifications, ensuring that specifications cite critical characteristics and required process controls, when required.
* Technically develop the supplier throughout the product development process to assure launch readiness, including development of supplier technical capabilities & control plans.
* Establish quality requirements for suppliers and initiate and manage quality agreements, when required.
* Ensure that proper risk control measures are implemented and monitored at the supplier.
* Assist in developing incoming inspection plans for components, assemblies and/or finished devices.
* Use appropriate methods such as statistical process control (SPC), advanced quality process (AQP) tools and metrics proactively to identify and implement improvement opportunities.
* Post-production activities
* Initiate and manage Supplier Corrective Actions (SAR) to ensure complete, timely and effective root cause analysis and corrective action implementation is performed promptly with the appropriate stakeholders.
* Applying risk management tools and concepts in the decision-making process for any identified opportunities, as well as for the prevention of non-conformances to occur at supplier level.
* Gather, monitor and analyze supplier quality data to identify trends and implement corrective action (Scorecards, KPIs, etc.) and prepare the data for the Quality Management Review.
* Manage Supplier Change Notices and provide leadership in managing the supplier change control process.
* Participate in the supplier quality audit process according to the pre-established calendar and ensure follow-up of corrective actions to audit findings
This list of functions is not exhaustive, and other tasks inherent to the position may be performed at the request of the line manager and/or in case of organizational change.
Your profile:
Technical skills
* Knowledge of requirements EU MDR, FDA, GMP, ISO 13485
* Knowledge of use of Quality tools/methodologies (CAPA, Data Analysis, Statistical Techniques)
* Knowledge of process analysis and continuous improvement tools [Lean, Six-Sigma, Poka-Yoke / Error Proofing, Measurement System Analysis, and Process Failure Mode and Effects Analysis (PFMEA)]
* Knowledge of Industrial processes
* Audit Techniques
* Advanced computer skills (Minitab knowledges appreciated)
Soft skills
* Ability to negotiate \"win-win\" situations with internal customers and external suppliers
* Ability to work in a highly matrixed, geographically and culturally diverse business environment
* Ability to participate in cross-functional teams and work with others
* Results Oriented & High degree of responsibility and accountability
* Leadership Skills
* Excellent verbal and written communication Skills
* Analytical thinking & Prioritization skills
* Qualified Engineer (Industrial or equivalent).
* Post graduate studies in matters like Industrial Engineering, Quality, Supplier Management, Operations or others related to the role.
* Fluent in English (written and spoken) and Italian
* Minimum five (5) years of work experience in highly regulated manufacturing environments and similar roles.