Quality Engineer – Medical Device Manufacturing

About the role

We are seeking a Quality Engineer to support medical device manufacturing at Biomerics. The role ensures compliance with regulatory standards and drives continuous improvement across production processes.

Key responsibilities

• Lead Quality Assurance activities for manufacturing in accordance with USFDA CFR 820, ISO 13485 and MHLW Ordinance 169.
• Manage validation projects and ensure all processes meet regulatory requirements.
• Develop, implement and maintain quality requirements during design transfer and product manufacturing.
• Identify, analyze and reduce manufacturing defects, scrap and customer complaints through root‑cause analysis and corrective‑preventive actions.
• Create risk analyses and conduct Failure Mode and Effects Analyses (FMEAs).
• Collect and analyse process defect data to support product and process improvement initiatives.

Required profile

• Experience in quality engineering within the medical device industry.
• Strong knowledge of USFDA CFR 820, ISO 13485 and MHLW Ordinance 169.
• Ability to lead cross‑functional teams and communicate quality initiatives.
• Familiarity with validation, risk analysis and FMEA methodologies.

Required skills

• USFDA CFR 820 compliance
• ISO 13485 standards
• MHLW Ordinance 169
• Risk analysis
• FMEA
• Validation activities
• Process defect data analysis