The Quality Engineer reports hierarchically to Quality Director of Biospringer France and functionally to Development and Application Director. The main  missions are :

Specifications Compliance :

• Manage the process of referencing and approval of products by the Procelys Customers
• Manage the Signature of Cahier des charges / specification
• Manage and implement the Signature of Quality agreement
• Involve in the processus of new cahier des charges with the Procelys’s Customers
• Integrate and develop the Customers Quality Requirements into Biospringer Quality System  in conjunction with the capability of the process and the recipe
• Promote solutions to be integrated into the recipe / production process to improve Quality Product for Procelys Customers
• Integrate all specification into SAP QM
• Manage and calculate the capability of each SKU following the specifications

Technical support for all Quality Aspects :

• Ensure a technical support to Customers to promote the use of Procelys Range
• Propose and participate in the implementation, of the new products and services, and or new implementation solutions
• Provide quality assistance to Sales peope/ Lab people / Technical Managers to ensure the good understanding  of the Procelys Customers requests and demands
• Provide the quality assistance to develop the new range and the new products

Claim Investigation in direct relation with Production sites :

Root cause analysis / Corrective action plan :

• Coordinate the record of customers complaint and the response in relation with Biospringer sites
• Determine the root cause, propose the corrective action and preventive plan
• Manage the Customer satisfaction on the Procelys Range

Customers Audits Management :

• Manage the audits in relation with Biospringer France Sites
• Organize and determine the corrective/ preventive actions requested by the audits in relation with Biospringer sites
• Communicate and follow the action plan

Batch Dossier / Batch records :

• Create and maintain the batch dossier in place
• Annual quality product review/ validation

Risk analysis :

• Evaluate the annual risk assessment
• Manage the annual batch record
• Manage the risk assessment on each projet
• Determine the specification to aim a First Time Release at 95%

Change Notification :

• Manage and communicate the change notification to Procelys customers 

Communication - Quality assistance / communication :

• Negotiation des quality agreement, specifications, analyses & méthodes, mise en place du principe pre-shipment sample
• Change managementet notification des changements au client (en s’appuyant sur les dossiers de qualifications)

Continous Improvement / Capability  / Gap analysis  :

• Manage and calculate the capability of each SKU following the specifications
• Propose solutions to get the First Time Release to reach 95%
• Integrate the new Customer’s requirements based on the capability of the process

Tools / KPI & Analysis :

• KPI : to promote and improve the Procelys product’s portfolio
• Monthly Reporting   : KPI claims/ Kpi Questionnaires

The position is in Maisons Alfort, with punctual business travels, worldwide (< 30%),

Travels in Manufactuering sites : Strasbourg, Cerences.

• Engineer in Food Industry, Biotech, or pharmaceutical industry or a  Master’s degree in Biochemical Engineering, Biotechnology, Biochemistry,  
• Minimum of 3 years‘ experience in QA or Production / Process development or Industrialization
• Minimum experience in Food company and Biotech/ Pharmaceutical company

Skills & Competencies :

• Key user SAP QM
• Good english skills, and a synthetic spirit / analysis
• Good communication skills, in particular the ability to explain technical subjects in a simple way
• Team player willing to collaborate in a matrix organisation
• Collaborative teams spirit