Quality Assurance Professional

5 dni temu


Poznań, Greater Poland LiNA Medical ApS Pełny etat
Job Overview

We are seeking a highly skilled Quality Assurance Professional to join our team at LiNA Medical ApS. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality in our medical devices.

Main Responsibilities
  • Support Non-Conforming Goods Process: Provide support in solving non-conforming goods issues, including overviews, counting, and journals in the ERP system.
  • Testing and Sampling: Assist in testing and sampling processes to ensure product quality.
  • QC Inspection: Conduct QC inspections on incoming, in-process, outgoing, and final products after sterilization, and document findings.
  • DHR/Purchase Specification Completion: Complete and review DHRs and purchase specifications to ensure compliance with regulatory requirements.
  • Document Creation: Create documents according to existing procedures, including GQS (D4) updates and creations.
  • CAPA Implementation: Implement corrective and preventive actions within the facility to ensure continuous improvement.
  • Quality Processes Participation: Participate in all quality-related processes, including NC, CAPA, and CR.
Requirements
  • Education: Bachelor's degree in a relevant field is required.
  • Experience: Experience from a similar position within the medical devices industry is welcome.
  • Language Skills: Fluent in English, both verbally and written.
  • Industry Knowledge: Familiarity with ISO 9001, ISO 13485, FDA, and MDD regulations.
  • Auditing Experience: Experience in auditing is an advantage.
  • Personal Qualities: Fast learning ability, open-mindedness, efficiency, accuracy, and a positive problem-solving attitude.


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