Arbetsbeskrivning

Technogarden Life Science has extensive experience from the pharmaceutical industry, scientific research, biotechnology, medical technology, and food production. We always work according to the latest standards and regulations, and with great personal commitment.

In order to support our clients in the best possible way, we offer both consultants and recruitment in Life Science and MedTech. Thus, we can provide guidance, training, and seminars about the latest regulations. We are attentive to the world around us and knowledge transfer is an important part of every successful recruitment or consulting job.

Quality Engineer | QA Specialist

Technogarden is currently recruiting a Quality Assurance Specialist/Quality Engineer within Medtech to a Stockholm/Solna based client that manufactures and markets assistive technology that supports communication, cognition, environmental control and personal safety. The company's products help people with disabilities and special needs live more independent lives.

You will join a collaborative organisation where quality, innovation and continuous improvement are part of everyday work, with the opportunity to develop your skills while contributing to products that make a meaningful difference.

About the role

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 organization. From time to time, you will also lead and/or coordinate quality related projects and improvement initiatives.

The position is based in Solna, Stockholm, or Gothenburg and is part of the Operations organization 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 corrective action

Who are you?

You are a process-oriented person who works well independently but also enjoy 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

• 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 within medical device.
• 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.

The position enables you to work either from Stockholm or hybrid from Gothenburg, traveling to suppliers and subsidiaries are part of the position. If you would like to thrive and develop within a small but high-paced company - this should be an interesting fit. We look forward to your application!