QA/RA Specialist

Job description
Do you want to be part of an agile, focused and friendly team? Do you want to work in a role with clear objectives and with the resources and freedom to deliver them? Then join a team of 15 experts focused on improving the lives of End Stage Kidney Disease patients around the world! 

Triomed is seeking a QA/RA Specialist to join their team. In this role, you will work closely with the Quality Manager and cross-functional teams to ensure that Triomed meets regulatory requirements and integrates the needs of the organization into their quality management system. As a QA/RA Specialist at Triomed, you will have a wide range of responsibilities and play a vital role in supporting quality and regulatory activities.  You will work closely with the Quality QA/RA Manager, who has a wealth of experience in the field. Specifically, you will assist in the submittal of regulatory applications for Triomed products on all applicable markets.  You will need to stay updated on new or updated laws, regulations, and standards that may apply to Triomed. Furthermore, you will be responsible for maintaining the quality management system through tasks such as writing and editing standard operating procedures and work instructions. You will also support R&D in the development of verification and validation protocols and reports. You will be involved in driving the risk management process and taking necessary actions to ensure adherence to risk management plans. You will promote awareness of product liability and design-quality issues across the organization and support internal, notified body and supplier audits. These responsibilities will help ensure that Triomed maintains its high standards of quality and compliance. Don't miss the opportunity to be part of a company that is dedicated to improving the quality of life for many dialysis patients around the world.

If you are interested in applying for the QA/RA Specialist position at Triomed, please visit www.randstad.se and submit your application by 2023-02-03. The selection process is ongoing, so it is advisable to apply as soon as possible. If you have any questions, please contact Senior Recruitment Consultant Emelie Lanner on emelie.lanner@randstad.se.

For us, it is important that all competences and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Responsibilities
Your most common tasks will be:


Support maintenance of Triomed QMS by contributing to writing and editing of SOPs and work instructions. 
Support R&D in development of vearification and validation protocols and reports 
Assist in the submittal of regulatory applications of Triomed products on all applicable markets. You may also assist in the preparation of IDE, 510(K), PMA, CE marking and other related regulatory filings.  
Stay up to date on new or updated laws, regulations and standards that may apply to Triomed.
Review DHR deliverables to ensure production activities comply with the DMR requirements. 
Communicate, liaise and co-operate with competent authorities and notified bodies. 
Lead the risk management process and take necessary actions to ensure adherence to risk management plan and promote awareness of product liability and design-quality issues across the organization. 
Support notified body, internal and supplier audits.


Qualifications
To thrive and succeed in this role, we believe that you bring the following experiences:


Relevant academic education. 
A few years of work experience in QA within Med Tech or pharmaceuticals. 
Competence within Risk Management according to ISO14971 or within RA.
Fluent in English, both spoken and written.

If you have experience with MDR for medical device class II or III products and have worked with medical technical products made of plastic, it will be considered advantageous. Additionally, competencies in the standard series 60601, risk management according to ISO14971 and RA, and knowledge of QSReg will be highly regarded.  Fluency in Swedish is also an advantage for this role.  

Triomed is seeking a candidate who is able to work both independently and in close collaboration with others. The ideal candidate has an eye for detail without losing sight of the big picture. They should be confident and thrive in a dynamic environment. 

About the company
Triomed is a medical technology company based in Lund developing systems for patients with kidney failure. Triomed’s systems are based on the proprietary Steady Concentration Peritoneal Dialysis platform. Proof of concept and pilot clinical trials have been completed and Triomed is currently preparing for a EU and US based registration trials and product commercialization.