- Postes vacants:
- 1 poste ouvert
- Type d'emploi désiré :
- CDI
- Rémunération proposée :
- Confidentiel
- Genre :
- Indifférent
Description de l'emploi
Purpose of Function
- Support ISO 13485 Quality management system implementation
- Manage the Quality controls.
- Support the improvement of the Quality Management System.
- Manage the quality inspector team and its effectiveness
- Monitor the measuring tools and clean room.
- Act as Internal auditor and provide technical support during third-party audits.
- Support the development of Risk Management activities in manufacturing phases.
- Support Supplier Quality Management.
- Manage the product and components non-conformities.
- Conduct and support internal and/or supplier’s audits, support during third-party audits.
- Support the improvement of the Quality Management System
Main responsabiluties and acoountabilities
- Define and implement quality control programs and documentation, organize the quality control activities in manufacturing and manufacturing process validation
- Integrate the results of the Quality controls to demonstrate the compliance to the acceptance criteria or predefined Quality requirement (maintain KPIs).
- Ensure that products are conforming to the requirements all along the manufacturing.
- Partner with Engineering and manufacturing for the investigation and correction of process failures. Ensure the development of comprehensive manufacturing process risk management
- Define the Quality strategy for the validation of manufacturing processes. Define the sampling plan and the control plan.
- Participate in the supplier’s management process (evaluation, certification).
- Ensure effective and efficient application of Quality Engineering tools and techniques (Statistical analysis, sampling plan determination).
- Participate to the finished products release
- Support CAPA related to his (her) activity
- Train and certify operators /inspectors to control or tests methods.
- Conduct and support internal and/or supplier’s audits
- Measuring equipment management: Calibration/verification planning.
- Monitor periodic microbiologic control and Clean room monitoring.
Exigences de l'emploi
Requested Qualifications (Education and Experience)
- Scientific education, high school or university graduation
- A few years’ experience in quality assurance, preferably in Medtech industry
- Knowledge of medical devices regulations, including Notify body and ISO9001/ISO13485 and reference standards applicable to the activity.
- Knowledge of risk management tools.
- Good understanding of descriptive and analytic statistics such as basic survey data analysis and statistical analysis.
- Working knowledge of Manufacturing process development.
- Basic knowledge in metrology.
- People management skills: ability to effectively direct the work of a group, to provide direction and foster the long-term learning and professional growth of others.
- Good command of English in writing and reading
- Excellent command of Microsoft Office package.
Personal Attributes
- Accountable, rigorous, results oriented.
- Excellent communication skills
- Entrepreneurial spirit, responsive, pragmatic and with an excellent sense of organization.
- People management skills.
Date d'expiration
18/03/2020