Quality Engineer - ISO 13485 | Continuous Improvement

Abilia AB; Stockholms kommun; On-site; SEK 520,000 - 680,000; Full time

Job summary

Abilia AB in Solna, Stockholm, is seeking a Quality Engineer / QA Specialist to ensure product quality across the supply chain and manufacturing process. You will collaborate with Development, Operations, Manufacturing and Regulatory Affairs, driving improvements and coordinating quality projects.

The role is part of the Operations organization and reports to the Quality Manager. You should have a technical background and 2–5 years of experience in quality roles, with ISO 9001/13485 knowledge

Qualifications

• Bachelor's degree in Engineering, Life Science or related technical field.
• 2–5 years in Quality Engineering or Quality Assurance.
• Knowledge of ISO 9001 and ISO 13485.
• Experience with quality tools: FMEA, RCA, 8D, CAPA, or Six Sigma.
• Strong analytical and problem-solving skills.
• Professional Swedish and English communication.

Responsibilities

• Support internal teams and suppliers to improve quality practices.
• Perform internal quality audits per ISO 13485.
• Lead supplier audits and follow up on findings.
• Initiate continuous improvement across products, processes and suppliers.
• Investigate quality issues and root causes.
• Analyze quality metrics and monitor defect trends.

Skills

Analytical thinking

Problem solving

Communication skills

Fluent Swedish & English

Education

Bachelor's degree in Engineering, Life Science or related technical field

Tools

FMEA

Root Cause Analysis

8D

CAPA

Six Sigma

Job description

Abilia AB in Solna, Stockholm, is seeking a Quality Engineer / QA Specialist to ensure product quality across the supply chain and manufacturing process. You will collaborate with Development, Operations, Manufacturing and Regulatory Affairs, driving improvements and coordinating quality projects.

The role is part of the Operations organization and reports to the Quality Manager. You should have a technical background and 2–5 years of experience in quality roles, with ISO 9001/13485 knowledge