Sterility Assurance Engineer, Senior Microbiologist

Sterility Assurance Engineer Senior Microbiologist

Based in the Stryker Montbonnot site 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.

**This job posting is currently for our recruitment pipeline purposes only**

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. Oversee / organize validations and requalification of the cleaning / cleanroom processes.
• Be the primary contact with the sterilization-related suppliers (e.g. sterilization provider test laboratories).
• Act as site SME for cleaning/cleanroom/sterilization processes.
• Supervise the monitoring of the cleaning/cleanroom/sterilization processes in compliance with applicable 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 content 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 (. 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.

Your Background:

Required:

• A minimum of 2 or more years experience in a similar role.
• Diploma in the field of microbiology/sterilization or biomedical engineering (master 2 or equivalent).
• Fluent in English and French (written and oral comprehension/expression).
• Skills in the statistical treatment of data and trend analysis.
• Problem-solving skills / root-cause analysis.

Preferred:

• Professional experience in the field of medical devices desirable.
• Experience in a Quality/Regulatory Affairs environment desirable.

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.

What we offer:

• Flat hierarchies and responsibility.Through flat hierarchies we strengthen the initiative and willingness of our employees to take over responsible tasks.

• We grow talent.At Stryker we offer great personal and internal career development for our employees with the possibility to make both vertical and lateral position movement.

• Team spirit & engagement.We create engaged and inclusive teams that encourage colleagues to share their diverse perspectives and opinions.

• Competitive salary and Benefits.With us you will receive a competitive salary and benefits commensurate with your job.

• Recognition of your performance.At our company outstanding individual and cross-functional team performance is rewarded. Ideas projects or other exceptional achievements can be submitted for various awards on a local and global level.

• Employee Resource Groups (ERGs). Our ERGs are dedicated to fostering an inclusive diverse and supportive workplace environment. They provide opportunities for development networking and collaboration and are open to all employees. Our ERGs are committed to promoting inclusion and belonging helping every individual thrive and contribute to our shared success.

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