Quality Specialist

At Rarity Bioscience, we are driven by innovation, purpose and the goal of radically improving cancer diagnostics. As part of our journey, we need your help to ensure our quality and regulatory excellence.

About the Role

In this role, you will be operationally responsible for the daily maintenance and ongoing development of the Quality Management System (QMS). It is a hands-on role in a dynamic environment where structure, ownership and cross-functional collaboration are essential. You will ensure the quality and regulatory compliance of our products and processes so that they meet both customer expectations and legislative requirements.

Key responsibilities:

• Managing document and record control.

• Handling batch release.

• Driving workflows related to complaints, non-conformities and change control.

• Conducting risk assessments and implementing control measures.

• Coordinating internal, external and supplier audits.

• Training team members on quality systems and procedures.

• Assisting with supplier evaluation and approvals.

Based at our Uppsala office you will report to the Director of Quality and Regulatory and contribute to us being a trusted provider of cutting-edge diagnostic technology. No challenge is too big and no task is too small, and as our company grows, your role will evolve.

Your Profile

We believe you are a few years into your career and bring experience from the Life Science industry. You should be comfortable managing processes, driving improvements and collaborating across functions.

You probably appreciate structure, to-do lists, and maybe even a good set of multi-colored pencils, and you naturally have a strong attention to detail and a process-focused mindset.

Required Qualifications

• A university or vocational degree in science, pharmacy, engineering, or a related field.

• Work experience in a regulated industry (e.g. pharmaceuticals, medical devices, or clinical laboratories).

• Experience with quality system processes such as quality control, complaint or non-conformity management, audits, change control, or supplier control.

• Professional proficiency in English, both written and verbal.

Preferred Qualifications

• Documented training in ISO 13485, ISO 9001, GxP, or similar quality systems.

But most of all, we are looking for someone who is eager to contribute. A team player with a flexible and pragmatic approach ready to roll up your sleeves.

What We Offer

Rarity is a young and fast-growing company with an agile and cross-functional work environment. You will be part of a team of dedicated and performance-oriented colleagues where the culture is built on openness, respect and diversity.

We are specialized in developing and manufacturing ultra-sensitive gene mutation detection assays for scientific and diagnostic use. Our operations follow the ISO 13485 quality management system for medical devices.

For more reasons to join, feel free to reach out to Sandra, she will gladly tell you more.

Application

We promise a dynamic and fun workplace where you can grow. Join us!

If you have any questions, please do not hesitate to contact Sandra Bydell Sveder, Senior Recruitment Consultant at SallyQ, at 0763199688 or [email protected].

Apply now and become a part of our mission to enable ulta-sensitive mutation detection and improve patient outcomes worldwide. We accept applications until 10th of June.