Junior Quality Engineer

About the role

The Junior Quality Engineer will support the Quality Assurance team in maintaining product quality and regulatory compliance throughout the product lifecycle. You will assist with quality control processes, documentation, and continuous‑improvement initiatives in a regulated medical‑device environment.

Key responsibilities

• Provide on‑line manufacturing quality support.
• Assist in developing, implementing and maintaining the Quality Management System (QMS) in line with FDA 21 CFR Part 820, ISO 13485 and other regulations.
• Execute quality control tests and inspections to verify product specifications.
• Participate in root‑cause analysis and CAPA activities.
• Assess and evaluate inspection gauges, test equipment and related technologies.
• Document and maintain quality records, test results and compliance reports.
• Support internal and supplier audits, as well as external regulatory inspections.
• Contribute to the creation and revision of SOPs, work instructions and quality procedures.
• Analyze quality data to identify trends, risks and improvement opportunities.
• Engage in lean manufacturing and continuous‑improvement projects.

Required profile

• Bachelor’s degree in a relevant field or equivalent combination of education and experience.
• Working knowledge of FDA 21 CFR Part 820 and ISO 13485 requirements.
• Proficiency in English (B2/C1 level).
• Previous experience in quality within a regulated industry is desirable.

Required skills

• Minitab or equivalent statistical analysis tool.
• Statistical analysis and data‑driven problem solving.
• Equipment and process validation.
• Quality Management System implementation (FDA 21 CFR Part 820, ISO 13485).