Validation Engineer 6-month fixed-term contract
il y a 5 jours
Implement and maintain qualifications and validations for equipment, processes and products in compliance with regulations and standards in force on all Affluent Medical Group projects
Mission start date: February 2026
JOB DESCRIPTIONRELATIONSHIPS AND/ OR FUNCTIONAL
Under the responsability of the Group Validation Manager, in conjunction with the teams (R&D, Regulatory Affairs, Quality and Clinical, Finance)
In exchange of information with the laboratories, consultants and subcontractors of the product manufacturing.
MAIN MISSIONS & ACTIVITIESProcess qualifications and product validation
- Monitor and maintain the annual validation plan (PVMP)
- Participate in defining and carrying out tests on the product (Draft protocols, test sheets and validation/qualification reports)
- Coordinate the execution of tests with laboratories and consultants
- Write and update procedures, instructions and Quality forms related to the qualification/validation activity
Product compliance and Quality support
- Check the compliance of sterilization cycles and microbiological tests
- Ensure that normative and regulatory requirements are taken into account in the input and output data for the design of medical devices,
- Participate in process and product risk analyses,
Participate in impact analyses and associated action plans as part of the Change control, NC, CAPA, COS process
RESPONSIBILITIESEnsure that activities are completed within a given time frame.
Maintain good relationships with subcontractors and consultants/laboratories
Plan and prioritize your activities in accordance with the instructions defined by your department manager. Present your activities to him with monitoring of indicators. Provide technical solutions to given problems.
SKILLS REQUIRED- Theoretical knowledge
Higher education in biomedical engineering
Knowledge of regulatory requirements associated with MD (European Directive 93/42 and 2017/745)
Standards: ISO QMS), ISO Risk management), ISO sterilization), ISO 14644 / ISO11737 / ISO19227 (microbiology), ISO 10993 series (biological evaluation), ISO packaging)
Aix-en-Provence
CANDIDATETo apply for this vacancy, please send your application to
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