Présentation de la société : EFE INTERNATIONAL
EFE International permet et facilite l’accès au dispositif Volontariat International en Entreprise (V.I.E) pour les Entreprises de Français.es à l’Etranger (E.F.E) .EFE International a été créée en 2021 afin de valoriser les entrepreneurs français dans le monde, avec un triple objectif :
- Développer le commerce extérieur de la France ;
- Renforcer les liens déjà existant des E.F.E avec la France ;
- Donner de nouvelles opportunités à de jeunes professionnel.les.
Missions
About the company :Natec Medical Ltd is an integrated design, development and manufacturing company specialized in Percutaneous Interventional Medical Devices for the global market. While our client base spans all six continents - with Asia currently representing our largest market - Natec is now actively expanding its CMO (Contract Manufacturing Organization) offering and seeks to strengthen its presence in North America through strategic partnerships with U.S.-based companies.
Main Purpose of the Role:
The Quality Engineer holds a cross-functional role working in close collaboration with Engineering, with the goal of supporting both regulatory compliance and the continuous improvement of the Quality Management System. This includes ensuring alignment with the highest international standards, particularly those applicable in the U.S. and European markets.
About the missions :
1) Quality Assurance
Supplier Quality Assurance:
- Ensure that products and components received from suppliers meet Natec’s specifications and quality standards.
- Support the qualification of new suppliers and the implementation of their quality plans.
- Monitor supplier performance through relevant KPIs and lead improvement initiatives when needed.
- Conduct supplier audits and support the implementation of supplier changes.
- Manage nonconforming materials and components from suppliers, including the implementation and follow-up of SCARs (Supplier Corrective Action Requests) .
- Collaborate with Purchasing, R&D and Incoming Inspection teams for the definition of incoming inspection plans.
- Ensure that manufactured products conform to Natec’s specifications and the DMR (Device Master Record) .
- Investigate and manage nonconforming products and deviations from the QMS or DMR.
- Review and approve updates to the DMR (e.g., work instructions or equipment qualifications) .
- Ensure the proper implementation of the DMR and associated controls on the shop floor.
- Support Production Engineering in the validation of special processes (e.g., coating, bonding or sterilization) .
- Assist Operations teams in controlling infrastructure, equipment, and tooling.
- Ensure that design and development activities comply with applicable regulations, standards, and Natec’s Quality Management System.
- Ensure that design and development plans are properly defined, executed, and monitored.
- Participate in the planning and execution of design and milestone reviews.
- Review deliverables from design projects and the Design History File (DHF) .
- Ensure that design inputs and outputs, as well as verification and validation activities, are complete, relevant, and traceable.
- Support the management of deviations, test failures, and risk analyses, including usability engineering.
- Perform audits of design and development activities.
- Lead and support continuous improvement initiatives for both products and processes.
- Define and monitor quality KPIs and analyze trends to identify opportunities for improvement.
- Participate in internal audits, as well as audits conducted by Notified Bodies and Competent Authorities.
- Support the investigation and implementation of CAPAs (Corrective and Preventive Actions) , both for internal issues and customer complaints.
- Support process changes in line with change control procedures, including coordination with Regulatory Affairs for external submissions.
- Review and improve quality procedures and work instructions for increased efficiency and compliance.
While this position does not involve direct team management, the Quality Engineer is expected to act as a leader in continuous improvement initiatives. These projects typically bring together cross-functional teams from various departments, requiring strong coordination skills and the ability to drive quality-focused actions across the organization.
3) Training & Development
The Quality Engineer plays a key role in quality training by developing training programs and delivering sessions to ensure that employees across the organization are properly trained on quality procedures, tools, and best practices.
4) Compliance
As a true ambassador of compliance within the organization, the Quality Engineer promotes a culture of quality by encouraging adherence to established rules and standards. They are also responsible for defining and maintaining the procedures necessary to ensure the compliance of the Quality Management System with applicable regulations and standards.
Key Performance Indicators and Metrics:
Key performance indicators for this position include the timely closure of nonconformities and customer complaints, as well as the effective implementation of corrective and preventive actions (CAPA) , in accordance with the annual objectives defined by the Quality department.This also includes the implementation of Statistical Process Control (SPC) tools to better identify trends and uncover opportunities for continuous improvement
Profil recherché
Qualifications & CertificationsA degree in engineering, pharmacy, or a Master’s degree in a relevant scientific discipline such as materials science, microbiology, or mechanical engineering is required.
Experience
2–3 years of experience in Quality, R&D, or Production within a highly regulated industry is preferred. However, junior profiles may also be considered based on their academic background.
Skills & Attributes
- Solid understanding of quality standards and regulations (particularly ISO 13485 and 21 CFR Part 820)
- Familiarity with risk management principles in accordance with ISO 14971
- Good command of special process validation principles (e.g. sterilization, packaging, bonding or coating)
- Proficiency in statistical techniques and use of tools such as Minitab or equivalent
- Ability to plan, conduct, and follow up on audits (internal and supplier audits)
- Fluent in English (both written and spoken)
- Strong structured problem-solving abilities
- Team player with a collaborative mindset
- High level of rigor and attention to detail
- Excellent written and verbal communication
- Ability to prioritize effectively in a dynamic environment
- Demonstrates focus, resilience, and adaptability in the face of change
- Capable of influencing others without direct authority