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.
Requirements: - Bachelors degree in engineering, quality assurance.
- Minimum 3-5 years of experience in quality within manufacturing of medical devices
- Experience with ISO 13485 and/or QSR part 820.
- Strong analytical and problem-solving skills.
- Excellent organizational skills and attention to detail.
- Ability to work cross-functionally and manage multiple tasks.
- Strong communication skills; fluent English.
This position is open to all candidates.