Quality Engineer to the validation team, TSS AB

Publiceringsdatum: 2024-11-29

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Jobbannons

Do you want to play a key role in ensuring the safe delivery of medicines worldwide? TSS, a leading provider of temperature monitoring and supply chain management solutions within the life science industry, is looking for a Quality Engineer. Could you be the person we’re looking for to help ensure safe and high-quality delivery through advanced temperature management solutions globally?

About the role

As a Quality Engineer at TSS you will be a part of the Validation team in Stockholm and play a key role in ensuring product quality. Your responsibility will include developing 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. You will collaborate closely with the product owners and development teams and other stakeholders to ensure our products meet regulatory requirements and deliver the highest level of performance.

Main tasks & responsibilities

• Develop and manage risk-based validation plans for products and processes confirming user requirements.
• Create, execute, and document test scripts for validations 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 practice in quality engineering.
• Support in backlog refinement with a quality and compliance perspective for early risk identification.
• Contribute to continues improvement initiatives within the Validation team.

About you

We are looking for a detail-oriented, self-driven individual with a strong focus on quality. The ideal candidate will be a proactive team player, possess excellent communication skills, and have the ability to solve problems effectively. With a strong sense of initiative, you will take ownership of tasks and drive continuous improvement while collaborating with colleagues across various functions.

Qualifications

• University degree in Life Science, Engineering or equivalent.
• Experience in validation processes and the qualification of both software and hardware systems.
• Strong understanding of regulatory requirements, preferably GAMP and FDA 21 CFR Part 11, with the ability to apply them in risk-based testing.
• Fluent in English, both written and verbal.
• Experience in software testing is highly meritorious, including test scripting, testing, test automation and reporting.

Application process

In this recruitment, TSS is collaborating with Mpya Sci & Tech. Submit your application directly via our website www.mpyascitech.com no later than January 5th. We work with ongoing selection, so don't hesitate to apply as the position may be filled before the application deadline. If you have any questions about the role, you are warmly welcome to contact Talent Advisors Erik Düring, +46 70-899 94 69, erik.during@mpyascitech.com, or Jasmin Khatibi, +46 76-163 63 00, jasmin.khatibi@mpyascitech.com

About TSS

For over 30 years, TSS has been at the forefront of temperature management solutions, ensuring the safe delivery of medicines to patients worldwide. The company collaborates with some of the most respected names in the life science industry, playing a key role in enabling safe and sustainable pharmaceutical distribution from start to finish.

The vision is to become the global standard for safe and sustainable drug delivery, with a mission to drive change in the global life science supply chain. Through an industry-leading cloud-based temperature management solution, TSS empowers the life science industry to ensure that medicines are delivered safely and efficiently to patients.

TSS has a robust quality management system in place and holds ISO 9001:2015 certification, as well as ISO/IEC 17025 certification for its temperature logger calibration laboratory.

Read more about TSS at www.tssab.com.