He/She defines, designs and implements manufacturing processes for production in accordance with Good Manufacturing Practices for medical devices developed by Affluent Medical in compliance with current quality and safety requirements.
JOB DESCRIPTION
RELATIONSHIPS AND/ OR FUNCTIONAL
N+1: Directeur Industrialisation Groupe
En échange d’informations avec la Direction de Programme (notamment formalisation des données d’entrée de design produits)
En échange d’informations avec les équipes Validation, Qualité, R&D et Affaires Réglementaires.
Support au déploiement des projets auprès des fournisseurs et sous-traitants.
En échange d’informations avec la Direction de Programme (notamment formalisation des données d’entrée de design produits)
En échange d’informations avec les équipes Validation, Qualité, R&D et Affaires Réglementaires.
Support au déploiement des projets auprès des fournisseurs et sous-traitants.
MAIN MISSIONS & ACTIVITIES
- Design and improve robust manufacturing processes in a Lean Manufacturing spirit
- Provide R&D with product specifications related to manufacturing constraints
- Write procedures, work instructions and all documentation necessary for the implementation of production resources
- Write the specification of user needs for new investments
- Define and write specifications for production and control resources
- Monitor investments, installation and qualification of production resources
- Participate in the risk analysis of manufacturing processes (internal and external in cooperation with suppliers)
- Participate in the referencing, qualification and periodic evaluation of suppliers and subcontractors
RESPONSIBILITIES
He/She is responsible for implementing the manufacturing processes of the manufacturing technology, as well as subcontracted manufacturing processes in collaboration with suppliers.
Key player in building and maintaining the DMR (Device Master Record – ref. FDA 21CFR820.40), in alignment with the process stakeholders for the DHF (Sr. Mgr. R&D) and the DHR (Mgr. Production & Quality).
Maintain up-to-date technical documentation, monitoring the efficiency of production processes, user training, management/maintenance of internal equipment.
Ensure monitoring of measurement means (calibration, documentation, etc.)
AUTONOMY
Plan his/her activities according to the priorities defined by his/her Manager
SKILLS REQUIRED
- Theoretical knowledge
Master Degree (type: Mechanics, Industrial Design, Electrical Engineering)
Knowledge of project management
Knowledge and understanding of the Regulations and standards applicable to MD (MDR, ISO 13485, FDA, etc.)
Mastery in lean manufacturing
Mastery of continuous improvement methods
Knowledge of cost accounting and product cost construction method
- Practical knowledge
English (reading, writing and speaking)
CANDIDATE
To apply for this vacancy, please send your application to jobopportunities@affluentmedical.com