Evimeria, part of Carasent is on an exciting journey within e-health and innovation, and we want to strengthen our Quality Team with a Quality Assurance specialist focusing on our new Management system, to support our vision of Enabling future care. We strive to build and implement our common processes and ways of working within the Carasent Group to enable and support organizational growth, product development and delivery of e-health solutions, as well as compliance to regulatory requirements and our MDR transfer. You'll be working from our Gothenburg Office but will support Carasent - together with the Quality Team.
We are in a scaling phase and growing rapidly within Carasent, building a new Quality Team and our new Carasent Management system (quality and information security), therefore we are searching for a Quality Assurance specialist with an interest in quality assurance and processes for medical device, document management and control, as well as orderly structures for documentation (controlling documents, records, as well as our library of standards and Regulations). We collaborate in the Quality Team, as well as interacts with all functions and process owners, but you will take the lead in the development and implementation as system owner of our new eQMS solution regarding document control, administration and settings and training to the organisation.
Challenges to handle
- System owner and administration in the newly purchased eQMS solution for the new Carasent Management System (quality and information security).
- Process owner of Document Management (SOP Document Control, SOP Standards and Regulations), SOP Risk based approach Management system processes, SOP Change management (general excl. design change products).
- Support to process owners in the organization in using eQMS and Change management.
- Coordination of change management within QA function areas of responsibility, including the eQMS solution and keep it in a validated state.
- List of standards and regulations updated, SIS subscription – coordination towards SMEs per standard (e.g. GAP analysis, follow up on actions, etc.)
- Subject matter expert (SME) for QMS related in MDR and EN ISO 13485 within the Carasent Group
- Experience from building and maintaining Management system for medical devices, plus if knowledge of medical device software and even better standalone software (SaMD/MDSW). Processes, SOPs (procedures), work instructions, guidelines and templates for related areas).
- Knowledge and understanding of common standards and Regulations for Medical device quality management system and QA, e.g., MDD/MDR, EN ISO 13485. Plus is knowledge of regulations GDPR and PDA, as well as standards related to risk management (ISO 14971), software development (e.g., IEC 62304, IEC 82304-1, IEC 62366-1), information for users (ISO 20417, ISO 15223-1) and information security (e.g., ISO 27001).
- Merit is knowledge/experience of eQMS solutions (electronic QMS, cloud based)
- Quality assurance mindset, structured and orderly.
- Easy to communicate, collaborate, coordinate and give support/trainings.
- Full professional proficiency in Swedish, excellent English skills, written and spoken
What's in it for you?
- An opportunity to be a part of scaling company with the aim of making a big impact on the global healthcare sector
- Development opportunities within a dynamic and fast-growing company
- Competitive compensation and good benefits
- 2 wellness hours every week + a wellness allowance
- 6 weeks of vacation + bridging days
- Environmental bonus, when choosing a climate-friendly transportation to the office
- Flexible working hours and freedom to partly work from home
Your manager for this position will be Ankie Sjöberg, Quality Assurance Director, Carasent. For questions about this position please contact Ankie Sjöberg firstname.lastname@example.org or Kajsa Conradi, Chief People Officer, email@example.com.
Carasent is a group focused on developing high-quality e-health solutions for the healthcare sector. Several of our systems are Electric Health records systems (EHR) which are medical devices. Through our subsidiaries, we want to enable people and synergies. We believe in innovation that offers a new kind of accessibility and availability for patients and practices. We offer intellectual and financial capital for stakeholders that want to provide high-quality services in this area of digital transformation.
Our journey started in the spring of 2018 when Carasent, acquired Evimeria EMR AB,a Swedish company that delivers web-based solutions within health. Our growth is based on providing our customers with modern and value driving solutions. Today, Carasent consists of around 160+ employees in Evimeria EMR AB, Avans Soma AS, Metodika AB and Medrave AB.