Q-linea is a public-listed diagnostic company that develops innovative solutions for improved infectious disease diagnostics, with a keen focus on improving sepsis treatment while reducing antibiotic resistance. The company focuses on developing instruments and consumables that benefit patients, healthcare providers and society.
Founded in Uppsala
Q-linea was founded in 2008 by scientists from the Rudbeck Laboratory at Uppsala University, together with Olink AB and Uppsala University’s holding company, UUAB. Today, Q-linea is a growing company comprises an interdisciplinary, highly motivated team of 100+ employees and consultants that operates out of state-of the-art, customised facilities in Uppsala Science Park and Fyrislund.
For more information, visit the company´s web sites at http://www.qlinea.com
Vision & mission
As an innovative pioneer, Q-linea helps to save lives by ensuring antibiotics continue to be an effective treatment for future generations. Q-linea develops and delivers preferred solutions for healthcare providers, enabling them to accurately diagnose and treat infectious diseases in the shortest possible time. Our solutions help healthcare providers worldwide to reduce the use of antibiotics by providing optimal treatment information for each patient.
Sr QA Engineer
Job Title: Sr QA Engineer
Reports to: Manager QA/RA
Q-linea is an innovative research, development and manufacturing company that primarily develops instruments and disposables for rapid and reliable infection diagnostics.
Q-linea is looking for a Sr QA Engineer that will provide expertise in Quality Assurance by participating in the day-to-day operation related to the design and manufacture of medical devices. The daily work will include maintenance of the Quality Management System (QMS) to ensure compliance to ISO 13485-standard and FDA´s QSReg and other relevant medical device standards. The Sr QA Engineer will work with a wide range of QA activities with regards to the quality, management and improvement of the products, processes and supply chain ensuring that the products developed and manufactured to meet applicable national and international legislations and regulatory requirements such as IVDD, IVDR, Parts of the FDA´s CFR Title 21 etc.
We are looking for a highly skilled and motivated person with at least 5 years´ quality management experience within the medical device industry. The person needs to be able to take decisions, be good in communication and having the ability to work across different teams, and good time management to drive performance.
Qualifications and experiences
• MSc or BSc degree within science or engineering or experience from a similar position
• A solid and documented experience (at least five years/deep understanding) of quality management within the medical device industry, is required
• Knowledge in medical device regulations (e.g. MDD/MDR, IVDD/IVDR, QSReg), the ISO 13485-standard and other standards related to medical devices
• Firsthand experience of audits by regulatory authorities (e.g. FDA, EU notified bodies)
• Handling non-conformities from manufacturing
• Experience in delivering QMS training
• Experience in supplier control activities
• Experience in leading internal audits
• Fluent in English and Swedish, oral and written
• Experience in Vigilance or Medical device reporting is an advantage
• Experience in risk management according to ISO 14971 is an advantage
• Experience in usability engineering according to ISO 62366 is an advantage
• Experience in EN 62304 Medical device software - Software life-cycle processes is a merit
• Ability to take decisions
• High level of self-motivation with the ability to operate independently and with minimum supervision when required
• Provides others with a clear direction
• Good communication, writing, and presentation skills in Swedish and English
• Ability to logically organize thoughts and ideas
• Strong attention to details and quality focus
• Work with a sense of urgency and having the ability to be unbiased and objective
• Ability to work across teams
• Good time management and meeting deadlines and commitments
• Ability to prioritize and manage multiple tasks
• Positive “can-do” attitude and a “doer”
Opportunities with the role
• To contribute to Q-linea’s very important mission; to help save lives by ensuring antibiotics continue to be an effective treatment for future generations
• The possibility to work for a very exciting Swedish Life Science company with a high growth rate and a huge potential to grow
• The possibility to work with very high quality, innovative and unique products that the society, healthcare and patients are asking for
• This is a key position, with the great opportunity to build, lead and develop the quality organization for the company to secure success in the future
• Work together with an experienced and very committed team, in a creative and very prestigeless environment
• The company culture is very attractive with a focus on community and development
• Be part of a successful expansive and dynamic company focusing on research, innovation and results to help the world to cover the threatening of antibiotic resistance
For more information and questions about the position, please contact Marta Frick Senior Recruitment Consultant at PeakSearch.
Marta Frick email@example.com Tel: 070-386 89 69