Do you want to work on medtech solutions that can save life?
Could you picture yourself in a rapid growing medtech-company? Does Software as Medical Device (SaMD) sound intriguing? Want to become a certified medtech developer? Does working in a dynamic environment at a fast growing company sound interesting?
Assuring Digital Health applications of the future
Dawn Health is looking for a Software QA Architect to help plan and execute development of Medical Device Software (MDSW) and GxP applications. We are looking for a qualified professional who see themselves equally in between Software and Quality, meaning your background may be either 1) anchored in Quality but with long work experience with Software Development, or 2) anchored in Software (e.g. as Lead Developer or Architect) with experience working with Computer Systems Validation.
Dawn Health develops software systems subject to ISO/IEC 62304 and/or ISPE GAMP 5 under its own Quality Management System on behalf of Customers in the Life science industry. Hence, in the position, you will be working closely with the Dawn Health Project Managers, Software Architects, and relevant Customer stakeholders in your work to plan qualification of MDSW and GxP Software Systems.
If you are not familiar with ISO/IEC 62304, ISO 13485 or ISPE GAMP 5 we will ensure you get the proper training, so that you can transfer your prior experience with Computer Systems Validation.
Depending on your motivation and aspirations, you may also become a key contributor to updating and maintaining the ISO 13485 certified Dawn Health Quality Management System.
Responsibilities of a Software QA Architect
- Plan, execute and maintain Quality Plans, Software Development Plans and Verification Plans (i.e. Unit, Integration, Regression and System Test) for critical projects.
- Support documentation of Quality, Development and Verification reports.
- Support Software Developers and Architects in documenting Software Architecture and Detailed Designs and orchestrate traceability to Requirements.
- Plan, execute and maintain Verification Plans for critical projects.
- Continuous improvement of internal Software Development Processes and Toolchain usage in Dawn Health with respect to quality and productivity.
Qualifications of a QA Architect
- You want “code to save lives” (Dawn Health company vision).
- You are an ambitious professional, motivated by combining your knowledge of Software with Computer Systems Validation.
- You have experience with aspects of Computer Systems Validation or Safety-Critical Systems (e.g. Finance, Aerospace, Defence).
- You have some experience with Software Development or Software Architecture.
- You have some experience with Operation and Maintenance of Software Systems.
- Your combined background with Software Development/Architecture and Computer Systems Validation is your key asset in bridging communication between Software Developers and Quality/Validation Specialists.
- You thrive in documenting complex Software Projects in consistent and well-structured manners.
- You have experience working with Software development projects, through exposure to Project Management, Requirements Specifications, System Testing or other documentation work.
- You have excellent written and spoken English and can maintain motivation when compiling large documentation packages.
Bonus points for a Software QA Architect
- Experience with Information Security Management Systems (ISO 27000 family, COBIT, NIST CSF or SP 800-53),
- Experience with IEC/ISO 62304, ISPE GAMP 5, ISO 13485, ISO 14971
- Experience with Mobile Application and PaaS Cloud Services
- Experience with Cloud Vendor Qualification
- Experience with ITIL, ITSM, COBIT
- Experience working with Software Requirements Management tools such as Azure DevOps or JIRA.
- You have already experienced the downsides of ill-defined or overly complex Software Design Documentation, Development Documentation, traceability.
- You have experience with developing Software applications, either as Software Developer or Architect.
Working at Dawn Health
Dawn Health is a digital health company specializing in software as medical device and broader healthcare solutions. We deliver strategic consulting and development of innovative digital therapies targeting patients on a global scale.
Working at Dawn Health is more than just a job. We are not just looking for new employees. We are looking for deeply passionate souls, gifted minds, innovators, team players, entrepreneurs and people who believe they can change the world. We love to build things, change the status quo and drive a new digital health agenda that will impact 1 million patients by 2030.
We hire people with a broad set of technical skills who are ready to take on some of technology’s greatest challenges and make an impact on millions of patients. At Dawn Health, engineers not only revolutionize the healthcare industry, they routinely work on innovation projects with the potential to become large-scale applications and entirely new digital health platforms. Get ready to dive into hypertension, diabetes, ostomy, brain diseases, cancer, infertility, growth hormone deficiency and bleeding disorders – as a MedTech engineer at Dawn Health you are changing the world one technological achievement after another.
iHeadHunt is the recruitment partner, and you can contact Malthe Andersen on +45 60 88 21 26 to learn more. Alternatively, you can send us your CV to email@example.com with the tag subject line “Dawn Health”. Application not required.
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