Arbetsbeskrivning

Do you want to be part of a team making a positive impact on the world? Do you want to contribute to solutions that benefit millions of people globally? Then you might be our new Quality Engineer!

For over 30 years, Temperature Sensitive Solutions Systems has been at the forefront of innovation in temperature management solutions. Working closely with the life science industry’s most respected companies, we are proud of our role in facilitating safe and sustainable end-to-end drug delivery.

For more information, please visit: https://www.tssab.com

TSS in short:

• 50+ passionate employees
• Technology built and enhanced in-house
• Products used worldwideOur vision: A world where every drug delivered to a patient is guaranteed to be safe – clearly, simply, and transparently.

About the role:

Our Validation team in Stockholm is now looking for a Quality Engineer. As a Quality Engineer at TSS, you will play a key role in ensuring product quality by developing validation plans, creating, and executing test scripts, and writing validation reports. You will also conduct hands-on testing to ensure our solutions meet the high standards required in the life sciences industry.

We are looking for someone detail-oriented, self-driven, and with a strong focus on quality. You will collaborate closely with our product owners and development teams and other key stakeholders to ensure our products meet regulatory requirements and deliver the highest level of performance.

What you will do:

• Develop and manage risk-based validation plans for products and processes confirming user requirements.
• Create, execute, and document test scripts for validation purposes.
• Write comprehensive validation reports.
• Conduct hands-on testing to ensure product compliance with quality standards.
• Participate in test automation projects to enable automated regression test suites
• Work closely with cross-functional teams to ensure adherence to regulatory requirements and best practices in quality engineering.
• Support in backlog refinement with a quality and compliance perspective for early risk identification.
• Contribute to continuous improvement initiatives within the Validation team

Who you are:

• 3+ years of experience in quality engineering roles in life science

• Experience with validation processes, test scripting, testing, test automation and reporting
• Strong understanding of regulatory requirements, preferably GAMP and FDA 21 CFR Part 11, with the ability to apply them in risk-based testing.

• Detail-oriented, self-driven, with a strong focus on quality.
• A collaborative team player with great communication skills.
• Fluent in English, both written and verbal.

Perks & benefits:

• Wellness grant to cover gym/yoga/massage costs.
• Hours dedicated to personal growth/education every month.
• Running coach two days a week/yoga in the mornings.
• Option for private health insurance.

Interested?

If you want to join our team, apply without a resume below with just your LinkedIn profile.