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CORCYM is a global medical device company. It has acquired a complete portfolio of surgical solutions with a heritage spanning more than 50 years. CORCYM employs approximately 850 people in over 100 countries, ensuring a strong presence to continuously support patients, healthcare professionals and healthcare systems worldwide.

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POSITION SUMMARY

This position reports to Principal Supplier Quality Engineer, Saluggia, within the Quality department.

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. The SQE is responsible for delivering all aspects of the Supplier Quality Assurance function.

He/She executes supplier audits as foreseen in the supplier audit program.

He/She collects root cause analysis and provides corrective feedback to prevent supply quality issues. In addition, the SQE manages the customer specific requirements and offers technical support to suppliers.

He/She is responsible for ensuring that the manufactured products meet quality standards required to minimize quality costs and maximize customer satisfaction whilst ensuring that procedures and processes are followed.

ESSENTIAL JOB FUNCTIONS

Responsibilities include, but are not limited to:

• Leads effective meetings, conducts presentations, keeps quality records, meeting minutes and action items

• Defines and implements initiatives to enhance system efficiencies, productivity, and quality that are consistent with company changes and growth. Supports and implements such changes without adversely impacting quality or regulatory compliance

• Reviews and approves components specifications, ensuring that they contain all required informations

• Technically develops the supplier throughout the product development process to assure launch readiness, including development of supplier control plans

• Assists in developing incoming inspection plans for components, assemblies and/or finished devices

• Initiates and manages quality agreements with suppliers

• Ensures that proper risk control measures are implemented and monitored at both the supplier and Corcym

• Educate suppliers on Corcym products, their intended use, and regulatory requirements

• Manages standards metrics (KPIs) for supplier process monitoring, analyzing supplier data, internally and externally gathered, to identify trends and prevent potential problems

• Manages the supplier change control process

• Initiate and manage Supplier Corrective Actions (SCAR, SQN) in partnership with Manufacturing/Process Engineering, Purchasing and Quality Engineering to ensure complete and effective root cause analysis and that corrective action implementation is performed in a timely manner

• Use appropriate methods such as statistical process control (SPC), advanced quality process (AQP) tools and metrics proactively to identify and implement improvement opportunities

• Collaborate with other members of the team to establish and maintain a meaningful supplier quality scorecard which is part of a bigger supplier scorecard that includes delivery, cost, partnership, etc.

KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

• Demonstrate use of Quality tools/methodologies: Knowledge of FDA, GMP, ISO 13485, and ISO 14971

• Ability to negotiate "win-win" situations with internal customers and external suppliers that meet Corcym's business needs

• Advanced computer skills, including statistical/data analysis and report writing skills (Minitab knowledges appreciated)

• Fluent in English (written and spoken)

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

• Work with Engineering (Design, Manufacturing and Quality Engineers) team to define process parameters and criteria to ensure supplier process capability is effective to meet product and process requirement

• Ability to promote the use of customer 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)

• Participate in cross-functional teams in the development of new products or changes related to current products in meeting customer requirements

• The SQE will be traveling to suppliers and need to be absolutely autonomous in moving around the world, and able to integrate into different cultures. His/Her success will be based on his/her adaptability and his/her understanding of the culture

• To be successful in this mission, the SQE must have a developed culture of cost management and a very structured mindset for continuous improvement

EDUCATION

Qualified Engineer or successfully completed University diploma on scientific disciplines.

EXPERIENCE

Minimum 3 years of experience in Quality Assurance or Engineering or R&D in a QS regulated industry (preferred Medical Device or Automotive).