Validation Engineer 6-month fixed-term contract
il y a 7 jours
Validation Engineer6-month fixed-term contract (maternity leave replacement) 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 DESCRIPTION RELATIONSHIPS AND/ OR FUNCTIONAL Under the responsibility 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 & ACTIVITIES Process 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 RESPONSIBILITIES Ensure that activities are completed within a given time frame.Maintain good relationships with subcontractors and consultants/laboratories AUTONOMY 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 13485 (QMS), ISO 14971 (Risk management), ISO 11135 (sterilization), ISO 14644 / ISO11737 / ISO19227 (microbiology), ISO 10993 series (biological evaluation), ISO 11607 (packaging) #J-18808-Ljbffr
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Medical Device Validation Engineer
il y a 7 jours
Aix-en-Provence, France Affluent Medical Temps pleinA leading medical technology company in Aix-en-Provence is seeking a Validation Engineer on a 6-month fixed-term contract. This role involves implementing and maintaining qualifications and validations for equipment and products to ensure compliance with regulatory standards. The ideal candidate will have a higher education in biomedical engineering and...
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