Quality Engineer

Medical Device company is seeking an experienced Quality engineer to join our team, directly reporting to QA/RA Manager.

The Quality Engineer will provide support for ensuring that products, processes, and systems meet internal quality standards and relevant regulations.

The role involves cross-functional collaboration, problem-solving, driving continuous improvement, and supporting both engineering and manufacturing teams in terms of quality.

Key Responsibilities:
- Maintain quality procedures, SOPs, and work instructions.
- Support compliance process with relevant standards such as ISO 13485, or other industry-specific regulations.
- Support internal and external audits.
- Handling nonconformities (NCRs) in production.
- Handling corrective and preventive actions (CAPA).
- Train teams on quality processes and best practices.
- Support suppliers' evaluation process.
- Support QC team as needed.
- Handling design changes (ECOs).
- Prepare quality reports, metrics, and presentations.
- Maintain accurate records in accordance with regulatory requirements.
- Provide support for other quality ongoing tasks.

The position is full time on-site.
North District - Shlomi.