Quality Engineer

Abilia AB; Solna kommun; On-site; SEK 520,000 - 700,000; 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. You will collaborate with Development, Operations, Manufacturing, Supply Chain and Regulatory Affairs, as well as external suppliers.

The role focuses on continuous improvement, risk identification, CAPA coordination, audits, and data analysis. You will report to the Quality Manager and contribute to strengthening quality processes within the

Qualifications

• Bachelor’s degree in Engineering, Life Science or equivalent technical discipline.
• 2–5 years in Quality Engineering/QA in regulated settings.
• Knowledge of ISO 9001 and/or ISO 13485.
• Experience with Q-tools: FMEA, RCA, 8D, CAPA or Six Sigma.
• Strong analytical and problem-solving abilities.
• Proficient Swedish and English communication.

Responsibilities

• Support quality systems and supplier quality across the supply chain.
• Perform internal quality audits according to ISO 13485.
• Lead supplier audits and address findings.
• Drive continuous improvement initiatives and CAPA processes.
• Investigate quality issues and perform root-cause analyses.
• Analyze quality metrics and monitor defect trends.

Skills

Quality mindset

Analytical thinking

Communication skills

Independent working

Collaboration

Education

Bachelor's degree in Engineering/Life Science or related

Tools

FMEA

Root Cause Analysis

8D

CAPA

Six Sigma

Job description

Who are we? Our goal is to simplify people's everyday lives, regardless of their needs. We want to give people with special needs the opportunity to participate and be independent. Abilia is a product and service provider for aids and welfare within the healthcare market. Today, we develop, manufacture and market aids for people with functional variations in the areas of communication, cognition, environmental control and alarms. We are market leaders and "thought leaders" in the field of cognitive aids. Abilia AB is part of the Abilia group, which has a turnover of over 400 million SEK and around 120 employees. The Abilia group has its home markets in Sweden and Norway but also has representation in the UK and internationally.

As a Quality Engineer | QA Specialist, you will play a key role in ensuring product quality throughout the supply chain and manufacturing process.

Working across the entire product lifecycle, you will collaborate with colleagues in Development, Operations, Manufacturing, Supply Chain and Regulatory Affairs, as well as with external suppliers.

You will contribute to continuous improvement by identifying risks, solving quality-related challenges and helping to strengthen quality processes across the organisation. From time to time, you will also lead and/or coordinate quality-related projects and improvement initiatives.

The position is based in Solna, Stockholm, is part of the Operations organisation and reports to the Quality Manager.

Key responsibilities

Quality systems and supplier quality

• Support internal teams and suppliers in improving and developing quality practices
• Perform internal quality audits according to ISO 13485
• Lead supplier audits and follow up on findings

Problem-solving and continuous improvement

• Initiate continuous improvement initiatives across products, processes and suppliers
• Lead and coordinate quality-related improvement activities/projects
• Support in the NC and CAPA process together with internal teams and suppliers
  • Be an important part of investigating product quality issues and root cause analyses

Product quality

• Support product verification, inspections and testing activities.
• Contribute to developing and maintaining inspection and testing procedures for incoming materials, in-process products and finished goods

Data and analysis

• Analyse quality metrics to identify trends, risks and opportunities for improvement
• Monitor defect rates and follow up on corrective actions

Who are you?

You are a process-oriented person who works well independently but also enjoys collaborating across different functions and building strong relationships with colleagues and suppliers. You are curious, eager to learn and motivated by finding practical solutions that improve products and the way we work through our processes.

You enjoy combining analytical thinking with a practical approach to problem solving. You are proactive, structured and comfortable taking ownership of your work.

We believe you have

• A Bachelor's degree in Engineering, Life Science or another relevant technical discipline, or equivalent experience.
• At least 2–5 years of experience within Quality Engineering and/or Quality Assurance, preferably in a regulated industry.
• Good knowledge of quality management systems such as ISO 9001 and/or ISO 13485.
• Experience working with quality tools such as FMEA, Root Cause Analysis, 8D, CAPA or Six Sigma.
• Strong analytical and problem-solving skills.
• Professional communication skills in Swedish and English, both written and spoken.