Supplier Quality Engineer

Fortil is an engineering company founded in 2009. We support our partners in the success of their technical projects in various fields such as Industry IT or Healthcare.
Today we are more than 2000 employees spread over 11 countries. Working with us means working in an ambitious team within a multicultural and international context!

Our ambition is to contribute to building a more responsible communal and inclusive world for our employees and clients.

We are currently looking for a Supplier Quality Engineerto support one of our client (biomedical sector)in province of Torino .

Job Description:

The Supplier Quality Engineer (SQE) represents the clientin managing the quality relationship with the suppliers throughout the supplier lifecycle from supplier qualification to the manufacturing and 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/98282 TGA and any other applicable regulation).

The purpose of the Supplier Quality Engineer role shall be achieved by:

Ensuring complaince to the Supplier Management procedure (MD00036)

Working with the supplier on their understanding of CRM products their intended use and regulatory requirements

Applying risk management tools and concepts in the decision making process for any identified opportunities as well as for the prevention of nonconformances to occur at supplier level.

Gather monitoring and analyzing supplier quality data to identify trends and implement corrective action (Scorecards KPIs Incoming Inspection yield etc.)

Managing Supplier Change Notices as Project Leader coordinating multifunctional group

Initiating and managing Supplier Corrective Actions (SAR) to ensure complete timely and effective root cause analysis and corrective action implementation is performed promptly with the appropriate stakeholders.

Identifing and help implement improvement to supplier quality management tools and processes

Participating in the supplier quality audit process according to the preestablished calendar.

Supporting CRM improvement initiatives related to suppliers (i.e. Purchasing group in Cost Reduction projects)

Collaborating with R&D in the development and communication to suppliers of component specification documentation

Working with the supplier on the development of their technical capabilities

Collaborating with R&D in the development of incoming inspection plans for components with the supplier & CRM ensuring the measurement system are equivalent and capable

Being responsible for any additional activity that might result from organizational changes strategic or operational that might be added to the activities and objectives here listed.

REQUIREMENTS

Engineering Degree in Industrial or related field

3 years of experience as SQE

Knowledge of requirements EU MDR FDA GMP ISO 13485 and ISO 14971

Knowledge of use of Quality tools/methodologies (CAPA Data Analysis Statistical Techniques)

Ability to negotiate winwin situations with internal customers and external suppliers

Advanced computer skills (Minitab knowledges appreciated)

Ability to work in a highly matrixed geographically and culturally diverse business environment

Knowledge of process analysis and continuous improvement tools Lean SixSigma PokaYoke / Error Proofing Measurement System Analysis and Process Failure Mode and Effects Analysis (PFMEA)

Ability to participate in crossfunctional teams and work with others

Next Steps

1. Someone from the Talent Acquisition department will contact you to schedule an initial HR interview.
2. If successful a second interview will be conducted to validate your technical knowledge.
3. In case of a positive outcome from the technical interview there will be a last qualification meeting with the Client.
4. If the final outcome is positive we will discuss our proposal with you. Alternatively if the outcome is negative we will share our sincere feedback!
   

Why Fortil

Although we currently find ourselves in a significant phase of expansion the high standards of our projects and recruitments remain as demanding as ever. Quality will always take precedence over quantity as we prefer excellence to ease!

We hope to become the largest independent engineering group in Europe working to serve future generations. To do so our operational model is based on four fundamental aspects:

• Profitable performance
• Expert engineers
• Efficient organisation
• Social responsibility

Apply and join us to become part of a model that is out of the ordinary!