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Quality Assurance Specialist
4 weeks ago
Senior Quality Assurance Specialist
About Sysmex-Astrego
The company was founded as Astrego Diagnostics in March 2017 with the mission to help in the global fight against antimicrobial resistance (AMR). Astrego Diagnostics was acquired by Sysmex Corporation, Japan in May 2022. Our team in Uppsala, Sweden combines multidisciplinary scientific excellence with seasoned entrepreneurs and diagnostic industry management.
Our AST system offers super rapid, sensitive, and precise Antibiotic Susceptibility Testing (AST) in a completely automated analyzer for use in near patient and central laboratory settings. It is utilized for detecting bacterial infection and susceptibility testing for Urinary Tract Infections (UTI) patients at the point of care, as well as other future applications related to bacterial infections.
About the Role
Sysmex Astrego is looking for a Senior Quality Assurance Specialist to join our growing team in Uppsala. In this role, you will be an integral part of our Quality Assurance & Regulatory Affairs team, working closely across departments to ensure compliance with industry standards and regulations. You will be part of a dedicated team of five professionals and report to the Quality Assurance & Regulatory Affairs Director.
Key Responsibilities
- Implement and maintain the company's eQMS (Greenlight Guru).
- Develop and maintain company processes and documentation in accordance with ISO 13485:2016, ISO 14971:2019, and IVDR 2017/746.
- Create, review, approve, and publish quality-regulated documentation.
- Participate in CAPA, Non-conformance, and complaint investigations.
- Lead and participate in risk management for products, processes, and equipment.
- Lead and participate in qualification and internal verification/validation of products, processes, and equipment.
- Lead and execute internal and external audits.
- Educate and ensure awareness of current QMS requirements for concerned Sysmex Astrego staff.
Qualifications & Experience
- Master's degree in a relevant field (e.g., Biology, Engineering, Quality Assurance).
- Minimum of five years of industry experience in a similar role within the medical device/IVD sector.
- Strong knowledge and experience working with and maintaining ISO 13485:2016 quality management systems.
- Experience with Greenlight Guru is a plus.
- Excellent verbal and written communication skills in both Swedish and English.
Personal Attributes
- Comfortable working in a dynamic environment and handling unforeseen situations.
- Detail-oriented and well-organized with a structured approach.
- Proactive and solution-oriented with a problem-solving mindset.
- Strong communication skills with the ability to collaborate effectively with internal and external stakeholders.
Why Join Us?
At Sysmex Astrego, we are committed to innovation of unique in vitro diagnostics. You will be joining a collaborative and forward-thinking team, where your contributions will directly impact our mission to improve healthcare. We offer a dynamic and international workplace with opportunities for professional growth and development.
Interested?
If you are ready to take the next step in your career, apply today We handle applications on an ongoing basis, so don't wait to submit your CV and tell us about yourself. We look forward to hearing from you.
For questions, please call Fredrik Englund at Briljant Rekrytering AB +46 70 612 65 65
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