Validation Engineer
6-month fixed-term contract (maternity leave replacement)

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.

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

Ensure 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.

• 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)

To apply for this vacancy, please send your application to jobopportunities@affluentmedical.com