QA Consultant

il y a 1 semaine

Kortrijk, Flandre, Belgique Pauwels Consulting Temps plein
For a high technology company in Zuid-West-Vlaanderen we are looking for a Quality Manager responsible for the following tasks:

  • Maintains and continuously improves the division quality management system in line with the business needs and compliant with the required standards and regulations for that region and/or division.
  • Plans, coordinates and conducts external certification, customer audits and internal audits. Calls for the required corrective actions, monitors the progress and escalates deviations to higher management.
  • Facilitates improvements and corrective actions (CAPA) with main focus on product corrective action process. Proposes, supports or leads improvement initiatives (short/midterm) for processes and practices.
  • Identify training needs and organize training interventions to meet quality standards and maintain own training matrix
  • Participates in NPI projects as Quality delegate and acts as Quality gatekeeper in NPI stage gate review meetings
  • Reports process / product performance figures, deviations, progress on quality performance or the need for improvement and changes in line with the divisional quality plan and objectives (e.g. inputs from customer surveys, field info,) has the authority to withdraw nonconforming products set / release production or delivery hold sign off CoCs (beyond CoC of manufactured products) and derogations
  • Coordinates customer escalations and requested QA meetings
  • Executes internal audits against QMS requirements
  • Involved in Agile software development
  • Collaborate with product owner in roadmap planning, sprint planning, sprint reviews to understand and prioritize issues, risks and opportunities
  • Provide inputs serving software release decisions, ensuring verification and validation activities are carried out by the software teams before release
  • Acts as the Management Representative for ISO9001 and/or ISO13485 for the site
  • Ensures the promotion of awareness of applicable regulatory and QMS requirements throughout the organization
  • Reports on the performance, effectiveness and improvement needs of the QMS to top management
  • Ensures the documentation of the processes needed for the QMS
  • Execute Quality Assurance responsibilities in medical devices risk management process and review technical documentation on sample basis

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