Sterilization R&D Scientist, Medical Devices

Lina Medical; Poznań; Híbrido; PLN 120.000 - 180.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Private medical care

Sports card

Flexible working time

English lessons

Descripción de la vacante

Lina Medical in Poznań, Poland, is seeking a Sterilization Specialist for R&D projects. You will oversee sterilization decisions, plan and validate sterilization qualifications, and coordinate microbiological tests with suppliers and in-house labs.

Responsibilities include ensuring regulatory compliance, supporting design and material choices for sterilization suitability, and transferring know-how to operations while aligning with QMS and ISO/DIR standards. A dynamic, international team awaits.

Formación

• Minimum 3 years of experience in Microbiology or Quality, ideally in Medical Device Industry.
• Knowledge of ISO 13485, ISO 14971, ISO 11135, ISO 11137, ISO 10993 is advantageous.
• Experience with quality tools and methods.
• Hands-on with device and laboratory equipment.
• Teamwork and workload prioritization.
• Willing to travel less than 5% of the time.

Responsabilidades

• Determine sterilization types balancing performance, safety, and cost.
• Develop, plan, execute, and document sterilization qualifications/validations.
• Organize sterilization studies and microbiological tests with suppliers and in-house lab.
• Prepare documentation to meet regulatory requirements for sterilization.
• Support product design and material selection for sterilization suitability.
• Transfer knowledge to operations team.
• Work with QMS and standards: ISO 13485, MDR 2017/745, ISO 11135, ISO 11137.
• Raise R&D awareness of sterilization aspects.
• Collaborate with project teams, QA, RA, suppliers and technical consultants.
• Report to line and project managers.
• Create QMS documentation related to sterilization in development.
• Participate in supplier qualifications, audits and claims related to sterility.
• Engage in root cause analysis and CAPA processes.

Conocimientos

Teamwork

Prioritize workload

Hands-on with device

Willing to travel

Quality tools knowledge

Herramientas

Metrological equipment

Laboratory equipment

Descripción del empleo

Lina Medical in Poznań, Poland, is seeking a Sterilization Specialist for R&D projects. You will oversee sterilization decisions, plan and validate sterilization qualifications, and coordinate microbiological tests with suppliers and in-house labs.

Responsibilities include ensuring regulatory compliance, supporting design and material choices for sterilization suitability, and transferring know-how to operations while aligning with QMS and ISO/DIR standards. A dynamic, international team awaits.