Quality Control Manager

The Company:
Join an innovative company specialized in the life sciences sector particularly in the field of medical technologies. Based in the ledeFrance region they develop and market advanced solutions for the detection and analysis of nucleic acids. They are renowned for their digital PCR platform. This platform utilizes innovative microfluidics and digital analysis to provide precise and reliable results making it a valuable tool for applications in molecular biology research clinical diagnostics and therapeutic monitoring. Join a company distinguished by its commitment to innovation and quality as well as its involvement in scientific research and the development of cuttingedge technological solutions to meet the growing needs of the medical sector. The company also strives to provide excellent customer service and to collaborate closely with researchers and healthcare professionals to address the most pressing challenges in the life sciences field.

The position:

The QC Manager is responsible for defining quality control processes for raw materials and finished products planning and implementing controls by managing the human and material resources necessary for their realization in compliance with regulations and hygiene and safety rules.

He/she ensures the quality of their products and alerts in case of major deviations or nonconformities that may lead to investigations.

He/she supervises a team of quality control technicians within the Manufacturing Operations (ManOps) department in close collaboration with the Production Methods and Continuous Improvement and R&D teams.

QC Laboratory Manager

In coordination with the Hygiene & Safety Manager:

• Ensure the supply and monitoring of the stock of products and reagents necessary for the controls
• Establish and enforce safety and hygiene rules within the laboratory
• Implement and enforce regulatory and quality requirements according to ISO13485 within the laboratory
• Supervise the monitoring of laboratory equipment ensure that all equipment is in good working order calibrated and validated for use supervise their repair or maintenance if necessary
• Define laboratory plans and improve them for optimized material and personnel flow.
  
  Transversal team management

In coordination with the Director of Industrialization & QC:

• Actively monitor the daily and weekly activities schedule of technicians
• Assist in prioritizing the schedule based on production constraints industrialization and other constraints as defined with the Director of Industrialization/QC
• Ensure good communication to disseminate essential information from management to the QC team and report on team performance
• Monitor team performance motivate them and listen to their needs to provide them with the means to achieve individual team and company goals.
  
  Quality Control of thier Products & DHR

In coordination with the Production & Purchasing teams:

• Define the QC schedule adapted to the supply and production schedule
• Perform or supervise the performance of QC manipulations for incoming control (raw materials) inprocess controls (semifinished products) and release controls (finished products)
• Plan and implement stability studies (normal aging accelerated etc.)
• Rigorously record traceability elements and results in tracking sheets reports or laboratory notebooks according to the applicable quality and regulatory framework
• Attach all traceability elements of the lots to the DHR (Device History Record) associated with the controlled lots verify the accuracy and completeness of the elements before transmitting the file to the QARA team.
  
  Continuous improvement of QC methods and tools

In coordination with the INDUS & QARA teams:

• Propose new QC methods or improvements to existing tools methods or quality criteria
• Validate the effectiveness and help implement new tests or quality criteria
• Train and participate in the onboarding of other team members to follow the scaleup of Operations
• Participate in QualityOperationsSupport (QUALOPS) meetings to report any problems or continuous improvement opportunities
• Participate in problemsolving groups establish and implement immediate and corrective and preventive actions (CAPA)

• Monitor the effectiveness of actions over time using control charts.
  
  Industrial Validation of new products/processes

In coordination with the R&D and Industrialization/Methods teams:

• Participate in defining the validation schedule adapted to the milestones defined for projects
• Contribute to the development of test plans for product validation or process qualification (Design of Experiments)
• Perform or supervise the performance of validation manipulations compared to a reference
• Ensure the traceability of experiments by recording protocols and results in QC sheets reports or a laboratory notebook according to established procedures
• Contribute to the valorization and communication of the results of experiments obtained through written reports or oral presentations and exchanges with the teams involved.

Profile Requirements:

• Minimum Bachelors degree in Biology with good scientific knowledge in molecular biology QC methods definition of AQL and data tracking
• Ideally with at least 2 years of experience in digital or quantitative PCR as well as fluorescence imaging
• Proficiency in Microsoft tools for data analysis planning and presentationsKnowledge of quality and regulatory standards in the field of MDIVD (ISO 13485 IVDD/IVDR ISO23640 etc.)
• Fluent in French and with a good level of English
• Ability to manage and negotiate with subcontractors accompany quality audits
• Autonomous organized and proactive the candidate enjoys coordination and transversality shows intellectual curiosity a strong team spirit and initiative.

Remote Work :

No