QA Engineer

Do you want to be part of a small, global and expansive medtech-company in Uppsala with the vision to win the fight against the world’s most common causes of death? Are you a curious and committed person who is driven by the opportunity to work with the best in the industry and to take great responsibility? Then the job as a QA Engineer at Coala Life is for you.

We’re expanding our quality department with a QA Engineer who will work as an integral part of the quality and regulatory team to maintain and improve our internal systems in an efficient way with the highest quality in the management of our products.  The QA Engineer will be responsible for and work in all aspects of quality systems for the product.

About Coala

Coala Life AB is a fast-growing Swedish medical technology company focused on cardiac diagnostics and mobile health. We develop and market patented products and services for digital remote monitoring, analysis, and screening of the heart and auscultation of heart and lung sounds. The head office is located in Uppsala, Sweden. Our Coala Heart Monitor is a medical device launched in early 2017 and is part of the Coala Pro service, which since 2018 has been offered to healthcare providers for cost-effective, simple, and digital remote arrhythmia monitoring.

Coala Life is a flexible and agile company in an expansion phase, where the initiation and implementation of changes to our processes are considered a natural part of the work. We believe that you are a curious, hands on, and organized problem solver with a passion for efficiency, process, and improvements.

In the role of QA Engineer, you will:

• Provide continuous and rigorous assessment of quality system including audit activities and applicable documentation to assure Coala Life’s compliance with internal policies, FDA regulations, ISO 13485, standards, and other governmental regulations
• Participate in and lead Quality System process activities including quality system projects, audits, and initiatives
• Assist in maintaining a quality and document management and training system compliant with regulatory and quality requirements
• Support management in corrective action, and preventive action (CAPA) activities in partnership with cross-functional departments
• Receive, categorize, and process complaints and customer feedback related to Coala products
• Collaborate with cross-functional departments to ensure timely implementation of document change requests
• Maintain accurate and timely correspondence and data
• Assist in the authoring and review of SOPs and applicable policies
• Perform other duties as assigned

We think you:

• Have technical competence through a Bachelor’s degree in Engineering, Computer Science, or other relevant technical field.
• 3-4 years work experience in Quality, Manufacturing, or regulated industry
• Are quality focused with a keen attention to detail and a high level of accuracy in your work
• Are proactive, service-oriented, and self-driven
• Have excellent oral, written, and interpersonal communication skills
• Are an active team player with good communication skills
• Are proficient in written and spoken English and Swedish
• Are proficient with Microsoft Word and Excel formatting tools and techniques
• Are flexible and adaptable to a fast-paced work environment
• Are reliable, organized, and able to focus on effective time management

Are you the one we are looking for?

We are always looking for rare talents. You have a sixth sense to make things happen, fast, and you love technology and design and of course you have a passion for doing good. You appreciate the high pace in a small and dynamic company, and you have experience of both quality and, preferably, regulatory requirements. Most certainly you are well organized, and you have a structured way of working. However, maybe the most important, you are a team player and you must have an ability and willingness to handle many different tasks and changes of priorities. You feel comfortable to align with colleagues to create practical and effective processes.

What can Coala offer you?

At Coala, you will have a great opportunity to develop in a global company with really high ambitions. Coala has received many awards and is ranked as one of the most exciting and promising health care growth companies in Sweden. Our new office in Uppsala, in walking distance from the train-station, will be your base but you can also work partially from home. This is a great opportunity to use and to strengthen your experience both in quality and regulatory.

Apply today!

This recruitment is handled by our recruitment partner, Moveup Consulting AB. To apply, please send your CV and a cover letter to tom.bergqvist@moveup.se

If you have questions regarding Coala Life or this open position, please contact Tom at +46 (0)733 87 2722 or Daniel Kremer at +46 (0)722 87 2724.

By submitting your application, you also consent to us storing your personal data, including CV & cover letter and that we have the right to share this information with third parties (our client). You can revoke the consent whenever you want.