Quality Engineer

Job Description – Quality Engineer

A 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.

Requirements

• Bachelor’s degree in engineering, quality assurance.
• Minimum 3-5 years of experience in quality within the 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.