Software quality engineer
R&D – Stockholm
Natural Cycles is looking for a Software Quality Engineer
We are looking for a Software Quality Engineer who is passionate about product quality and enjoys coordinating quality activities and support the design and software development team members. You will also be responsible for validating software used internally both within product development and maintenance as well as in other departments.
What you will be doing
- Develop, refine, and execute our internal software testing processes and contribute to the quality of our application.
- Work with project teams to ensure standard quality practices/processes are followed
- Document and report test outcomes; work collaboratively with programmers and others as a member of a team and across organizations to learn processes and the impact of desired changes on applications; and follow procedures applicable to regulated environments as they apply to computer system validation
- Understand organizational business processes and how proposed computer system changes will impact users and processes.
- Making sure product compliance is achieved throughout the lifecycle of the product
- Coordinating quality activities such as risk management and verification during software design, development and maintenance:
- Training the R&D team
- Creating awareness of regulatory requirements
- Creating and updating technical file documentation and SOPs.
- Empowering representative of IT ensuring security measures are incorporated into strategic IT plans with clear IT security requirements and risk control implementation.
- You will be expected to develop a deep understanding of our products and how they are used by our clients, and to apply that knowledge to the quality assurance and testing process.
What skills and experience you should have
- Strong technical background to deploy information security for endpoints, network, data, and identity & access management as well as to perform the validation of applicable software services used within the company
- Strong experience of quality assurance in software as medical device
- 4+ years experience in Quality Assurance and software development
- Demonstrated understanding of business need versus compliance
- Experience of a strictly regulated business environment is essential (e.g. Regulatory affairs, Clinical, Medical, Pharmaceutical, Finance)
- Experience in IEC 62304, ISO 27001, ISO 13485, and ISO 14971 is essential as well as relevant recognized standards and ability to interpret regulatory requirements to clear and understandable instructions
- Experience in Medical Device Directive 93/42/EEC is prefered
What type of person we are looking for
- Good cross functional communication skills
- Good project management skills
- Excellent technical writer
- Strong influence, organisational and communication skills
- Motivated, proactive, independent, flexible and adaptable
- Ability to thrive in a dynamic, fast-paced work environment
- Ability to work under pressure and within time constraints
- Excellent English, verbal and written
You will be working full time with us on location in our office in Stockholm.
As we have customers and employees from all over the world, it is very important that you are free from prejudices against different cultures, religious views or ethnicities.
Great emphasis is placed on personal matching for this position. Preferably, we aim to fill this position by the middle of February 2018.