Senior Microbiologist

Job summary

The Senior Microbiologist within QA (Quality Assurance) department is responsible for the compliance of Stryker products in accordance with relevant regulatory requirements and standards for medical devices.

The Senior Microbiologist ensures sustained levels of cleanliness and sterility compliance through testing, monitoring and validation of sterilization processes and associated utilities.

Primary responsabilities

The Senior Microbiologist works within the QA Microbiology & Sterilization team, with responsibility to ensure effective and efficient cleanliness and sterility practices, which includes, but not limited to the following:

• Conduct the validations and requalifications of the sterilization process, in compliance with the applicable standards. Be the primary contact with the sterilization-related suppliers (e.g., sterilization provider, test laboratories)
• Supervise the monitoring of the sterilization process, in compliance with applicables standards (products, consumables, environment, etc.).
• Establish Monitoring Plans and associated Sampling for validations and requalifications.
• Analyze the sampling/monitoring data using statistical techniques and to determine the process management and trends. Establish the limits, identify and initiate control measures in case of drifting.
• Oversee the testing related to microbiology/sterilization of components, materials and consumables.
• Act as local expert regarding regulatory requirements and applicable local procedures while ensuring that these procedures are kept up to date.
• Support and train other onsite functions for activities related to microbiology/sterilization, ensure that the contain of these trainings is relevant.
• Take part in the change control process: create impact analysis and implement identified actions.
• Manage the initiation and closure of NCs and CAPAs. Provide technical evaluation for risk analysis activities.
• Ensure the compliance of new products / processes with applicable standards and specifications.
• Lead technical projects and continuous amelioration actions.
• Write / approve the associated technical documentation.
• Reports regularly on the ongoing actions, costs, delays, events, budget, risks and control measures to the QA Microbiology & Sterilization and the management.
• Have a technical specialist role in microbiology/sterilization within Stryker networks, in particular for questions related to problem solving and root cause analysis, projects, etc.
• Support regulatory activities linked to his/her scope (e.eg., take part in the constitution of technical files, provide responses to notified bodies).
• Be the local specialist for microbiology/sterility related topics in the case of internal / external audits.

Education

• Diploma in the field of microbiology/sterilization (master 2 or equivalent).
• Fluent in English ( wri tten and oral comprehension/expression).
• High level with general professional softwares (Microsoft office).

Qualification, work experience

• Minimum 3 years professional experience; ideally in the field of medical devices.
• Experience in a Quality/Regulatory Affairs environment desirable.
• Skills in the statistical treatment of data and trend analysis.
• Problem-solving skills / root-cause analysis.

Soft skills

• Strong interpersonal skills, communication within the structure and outside the structure.
• Must possess strong communication skills as well as the ability to manage multiple tasks simultaneously.
• Critical thinking skills.
• Organization abilities.

France Pay Ranges:

• France : €41.300 - €68.800 EUR Annual

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