Qualification/Validation Engineer

Barrington James

  • Côte-d'Or
  • CDI
  • Temps-plein
  • Il y a 1 mois
Job DescriptionBarrington James is delighted to be partnering with a pioneering medical device company that is rapidly emerging as a global leader in the sports medicine space. This collaboration presents a unique opportunity to be part of a high-growth, innovation-led environment at the forefront of cutting-edge Class III medical advancements.Our client is currently seeking a skilled Operational Quality Technician to join their team onsite in Dijon, France. This is a full-time, onsite role, offering the chance to contribute directly to the company's quality operations and continued success.General Mission / Purpose of the Position:Under the hierarchical responsibility of the Quality Assurance/Regulatory Affairs Manager, your mission will be to contribute to Operational Quality activities to ensure compliance with applicable standards (Regulation 2017/745, ISO 13485, etc.).Description of Activities:
  • Production Quality Control: Perform or supervise in-process inspections, sampling, and identification;
  • Participate in product release activities to support the continuity of QARA service operations;
  • Prepare and oversee validation batch execution with the Production department;
  • Lead the definition and implementation of information supply processes (Label printing, Instructions for Use);
  • Lead the metrology monitoring activities of equipment;
  • React to issues and lead problem-solving processes;
  • Manage non-conformities and the implementation of corrective and preventive actions (CAPA) related to products;
  • Ensure monitoring and analysis of laboratory test results and participate in statistical data analysis;
  • Participate in Supplier Quality activities related to the manufacturing of medical devices with relevant departments: Specifications, Approval, Integration, and Supplier performance monitoring, Non-conformity management;
  • Supervise maintenance activities related to the Management of Material Resources.
Hierarchical / Project / Team Leadership Responsibilities:Lead meetings for problem-solving, continuous improvement, and change control.Internal / External Working Relationships:
  • Internal: Collaboration with Production, R&D, and Quality/Regulatory departments;
  • External: Suppliers, service providers, auditors, and consultants (non-exhaustive list).
Profile Requirements:
  • 2-year degree (Associate level or higher) in Process Control, Industrial Engineering, or Quality;
  • Minimum 3 years of experience in Operational Quality;
  • Confidentiality;
  • Strong interpersonal skills to communicate with various stakeholders;
  • Organized, precise, and rigorous;
  • Autonomous;
  • Adaptability.
If this opportunity is of interest and aligns with your skills, please apply or send a copy of your up to date CV to kpiper@barringtonjames.com

Barrington James