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.
– 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.
