Conduct internal and external quality audits.
Develop quality procedures and policies.
Provide support for registration processes.
Ensure compliance with MDR regulations.
Lead the implementation of quality standards within the company.
Prepare protocols and reports.
Guide and validate processes.
Manage the quality system.
Parallel management of multiple tasks with the ability to prioritize.
Develop quality procedures and policies.
Provide support for registration processes.
Ensure compliance with MDR regulations.
Lead the implementation of quality standards within the company.
Prepare protocols and reports.
Guide and validate processes.
Manage the quality system.
Parallel management of multiple tasks with the ability to prioritize.
Requirements:
Bachelor's degree in Biotechnology, Life Sciences, Biomedical Engineering, or a related field.
Familiarity with ISO 13485 requirements and European MDR regulations.
Certified Quality Engineer (ICQE/CQE) – an advantage.
Experience in preparing and accompanying external audits – mandatory.
Experience working with Notified Bodies – mandatory.
Ability to work with multiple interfaces.
Fluent in English (native level).
Russian – an advantage.
Ability to work collaboratively and independently.
Bachelor's degree in Biotechnology, Life Sciences, Biomedical Engineering, or a related field.
Familiarity with ISO 13485 requirements and European MDR regulations.
Certified Quality Engineer (ICQE/CQE) – an advantage.
Experience in preparing and accompanying external audits – mandatory.
Experience working with Notified Bodies – mandatory.
Ability to work with multiple interfaces.
Fluent in English (native level).
Russian – an advantage.
Ability to work collaboratively and independently.
This position is open to all candidates.
