Solna, Sweden · On-site
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 provide…
Skills: Quality Engineering, Quality Assurance, ISO 13485, ISO 9001, FMEA
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Ensure product quality across the supply chain and manufacturing process by collaborating with cross-functional teams and external suppliers. Lead quality audits, manage the CAPA process, and drive continuous improvement initiatives to reduce defects.
Requires a Bachelor's degree in Engineering, Life Science, or a related technical field with 2-5 years of experience in Quality Engineering, preferably in a regulated industry. Proficiency in ISO 13485/9001 and quality tools like FMEA and Root Cause Analysis is essential.
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.
Application
For the recruitment of this role we partner with Inizio Engage who is managing this recruitment process on behalf of Abilia.
Applications are reviewed on an ongoing basis, and the recruitment process will close once the right candidate has been selected. If this sounds like the right opportunity for you, we encourage you to submit your application as soon as possible.
Rätt hjälpmedel i rätt tid kan göra verklig skillnad.
Abilia gives people with special needs the power to become independent and take control of their daily lives. Based on our more than 40 years’ experience and supported by research evidence, we know that our assistive technology helps people to get structure over their day, to communicate with people, to control appliances in their home and call for attention. We believe that everyone should have the same opportunities to participate in society on their terms, and are passionate about enabling people access to a more fulfilling life. Abilia develops, manufactures and sells aids for individuals with disabilities in the areas of communication, cognition and environment control & alarm. We have offices in Sweden, Norway, and the UK, and export our products to another 20 countries. Abilia is a merger of the four companies Gewa, Falck Igel, Handitek and Toby Churchill. Our turnover currently amounts to about SEK 200 million. Abilia is owned by MedCap, a Nordic investor that focuses on established Life Science companies with significant development potential. MedCap has been part-owner in the former GEWA AB since 2007. Read more about Abilia at www.abilia.com. For more information on Medcap, please visit www.medcap.se
Offices: Råsundavägen 6,, Solna, Solna 169 67, SE · Tevlingveien 23, Alna District, Oslo 1081, NO · Buckingway Business Park, Unit 12, Swavesey, England CB24 4, GB
Rätt hjälpmedel i rätt tid kan göra verklig skillnad.
Abilia gives people with special needs the power to become independent and take control of their daily lives. Based on our more than 40 years’ experience and supported by research evidence, we know that our assistive technology helps people to get structure over their day, to communicate with people, to control appliances in their home and call for attention. We believe that everyone should have the same opportunities to participate in society on their terms, and are passionate about enabling people access to a more fulfilling life. Abilia develops, manufactures and sells aids for individuals with disabilities in the areas of communication, cognition and environment control & alarm. We have offices in Sweden, Norway, and the UK, and export our products to another 20 countries. Abilia is a merger of the four companies Gewa, Falck Igel, Handitek and Toby Churchill. Our turnover currently amounts to about SEK 200 million. Abilia is owned by MedCap, a Nordic investor that focuses on established Life Science companies with significant development potential. MedCap has been part-owner in the former GEWA AB since 2007. Read more about Abilia at www.abilia.com. For more information on Medcap, please visit www.medcap.se
Offices: Råsundavägen 6,, Solna, Solna 169 67, SE · Tevlingveien 23, Alna District, Oslo 1081, NO · Buckingway Business Park, Unit 12, Swavesey, England CB24 4, GB
