Kalios operational quality specialist

N+1: Head of Quality
Exchanging information with the Regulatory Affairs, R&D, Manufacturing, Industrialization departments, etc.
Exchange information with the supplier quality manager.
Provide technical assistance and support during development, testing and manufacturing at suppliers (components, etc.).
Support internal and external audits and inspections as a device quality expert.

• Define, review and approve production documents (work instructions, operating procedures, batch records, pFMEA).
• Provide R&D, production and industrialization teams with advice and decisions on quality and compliance.
• Contribute to the drafting of manufacturing processes and design transfer to ensure product compliance and robustness.
• Ensure compliance with quality requirements during production and industrialization operations by reviewing and approving batch records.
• Review and approve non-conformities and lead strategic discussions for investigations related to operations or validation/qualification issues.
• Review potential concessions associated with non-conformities.
• Review and approve corrective and preventive actions (CAPA) relating to facilities, the quality control laboratory or products.
• Evaluate, approve, and support the timely processing of changes related to manufacturing operations.
• Conduct internal audits, such as self-inspections.
• Ensure the sustainable and continuous improvement of the quality management system and best practices for device lifecycle processes by identifying areas for improvement and engaging in corrective actions.

He/she oversees the development, implementation and continuous improvement of quality processes and procedures related to devices and ensures compliance with standards and regulatory requirements applicable to medical devices.
Ensure that appropriate qualification and validation assessments are carried out.
Ensure quality monitoring of manufacturing areas and warehouses.

The Operational Quality Specialist works independently and makes decisions in accordance with applicable objectives, priorities and procedures. However, any issues relating to the compliance of products and processes within the quality management system must first be discussed and decided upon with the Quality Director.

He/she reports any safety or performance issues to the Quality Director.

• Theoretical knowledge
  Higher education in pharmacy, biological engineering or chemical engineering.
  Project mode focusing on the analysis of production problems and applied problem-solving methods.
  Knowledge of standards relating to the sterilization of healthcare products (ISO 11135, ISO 11137, etc.).
  
• Practical knowledge
  Minimum 3 years’ experience in operational quality or equivalent
  Knowledge of standards and regulations relating to medical devices (ISO 13485, ISO 14971, MDR 2017/745).
  Proficiency in problem-solving methods and quality tools.
  Qualification in internal and external audit practices.
  English (read, spoken and written).