QA/RA Specialist to innovative Sysmex Astrego

Would you like to contribute to reducing antibiotic resistance? Would you like to bring your experience from working with Quality Management Systems to a young and developing company where your QA skills are highly appreciated? Then the open position as QA/RA Specialist at Sysmex Astrego is an opportunity for you.

Earlier this year Sysmex Astrego’s system for detection of bacterial infection and antibiotic susceptibility testing for patients with urinary tract infections was CE IVDD marked. Now there is a chance for you with a solid background in QA/RA to join this exiting company taking their next steps to make their system available also in the US and Japan.

If interested, do not hesitate to apply at once as we will review applicants continuously and the position needs to be filled as quickly as possible.

To assure the best match for both the candidate and the customer, we at QRIOS use tests as objective and validated tools in addition to more subjective parts of the recruitment process such as interviews and references.

 

About the position

As QA/RA Specialist at Sysmex Astrego, you will have a broad scope of responsibilities related to mainly quality but also regulatory compliance with focus on further develop and strengthen the Quality Management System (QMS). As the company is young, the QMS is too, and is implemented as an electronic QMS using Greenlight Guru. Following the CE self-declaration, earlier this year, the focus is now filing and approval in the US and Japan, and the eQMS must be developed accordingly. The organisation emphasises the necessity and benefits of a relevant QMS and you will work closely with colleagues in all departments to evolve the quality culture.

The role as QA/RA Specialist is a full-time permanent position based in Uppsala.

Responsibilities

Your main responsibilities as QA/RA Specialist will be:

  • Support in developing and maintaining processes in the QMS

  • Manage the further development of the QMS including processes for e.g., complaints, NC, CAPA and PMS

  • Ensure efficient implementation of applicable quality regulations and standards such as IVDR/D, FDA 21 CFR 820 and ISO 13485:2016 to sustain compliance

  • Conduct QMS training for all staff as necessary

  • Be responsible for Risk Management and perform risk analyses

  • Perform internal audits and external audits as needed

  • Actively coordinate and contribute when audited by external parties

Your profile

As QA/RA specialist we expect you to have the following qualifications:

  • At least 5 years of working experience in a similar role, preferably within IVD

  • Previous experience of maintaining, developing and implementing QMS processes while ensuring compliance to applicable regulations and standards

  • Fluent in English on a professional level, both oral and written

  • Computer skills including Microsoft Office

  • Good knowledge of risk management and ISO 14971:2019 is meritorious

  • Preferably experienced in coordinating and actively participating in audits by external parties

  • Knowledge in microbiology is an advantage

When it comes to personal traits, you are well organized, curious and genuinely interested in how processes and daily work are performed in practice throughout the company. You enjoy working hands-on with tasks related to the QMS and supporting the organization in this area. You are proactive, you take initiatives when you identify improvement opportunities, and you contribute to finding new approaches in solving issues. You have great communication skills, strong engagement and you embrace team diversity.

 

About the Organisation

Sysmex Astrego AB is a rapidly growing in vitro diagnostic company based in Uppsala, Sweden. After a decade of fundamental research, the company was founded in March 2017 with the mission to help in the global fight against antimicrobial resistance (AMR). On May 2, Sysmex Corp., a Japanese world leading diagnostic company, acquired Astrego which is now part of a global organization comprising 10 000 employees. 

The company name comes from Antibiotic Susceptibility Testing – AST, and rego – being Latin for guide, steer or manage. Our products are designed to guide physicians in the selection of effective antibiotic treatments to improve patient outcomes and make antibiotic stewardship easy.

Our team combines multidisciplinary scientific excellence with seasoned entrepreneurs and diagnostic industry management.

www.astrego.se

Fakta

  • Bransch

    Life Science

  • Stad

    Uppsala

  • Sista ansökningsdag

    2022-07-11

  • Ansök här

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