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5 dni temu
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.
- 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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