Join the most committed people in IT
We are looking for
We are starting to create new processes connected to medical industry in embedded software development. We are looking for Quality Engineer, who will support us in ISO Management System development and (depending on experience) who will take the leading role in setting-up SW development lifecycle for Medical Devices industry.
- Provides support in process deployment, operations and monitoring both at organizational (ISO9001 and ISO27001) and project level.
- Provides support in organizational and project process definition for Medical Devices industry
- Provides independent assurance that process and work products comply with predefined provisions and plans.
- Acts as a gate keeper for quality of deliveries to customer or next development level
- Checks process compliance against the process, tracks and closes Action items related to quality.
- Participates in processes reviews, improvement initiatives
- Provides consultancy and coaching on processes, procedures to Project Engineering Teams
- Creates and maintains Quality Plans
- Provides Quality-related trainings
- Executes internal audits according to Internal Audit Programme
- Previous experience in quality engineering / quality specialist roles
- Experience and familiarity with management systems (ISO 9001 – obligatory, ISO27001 – optional)
- Experience in software industry and software development lifecycle
- Experience and/or familiarity with ISO 13485, IEC 62304, FDA QSR
- Experience and/or familiarity with medical devices risk management and ISO 14971
- Can-do attitude and willingness to learn
- Analytical mind, detail-oriented
- Excellent communication, presentation and negotiation skills
- Very good English (written and spoken)
Meet the recruiter
WHAT YOU CAN GET
We support you at every stage
Decide on your development. Go to a conference, learn a new language or buy a selection of books in your field.
In most projects, each specialist can work one day a week from any location.
Flexible working hours
You're not an early bird? You can work for us when you are the most productive.
Choice of equipment
You choose which equipment will work best for you.
Every specialist has an assigned person who takes care of their career development.
Private health care
We have several packages from two suppliers to choose from, without waiting in queues.
Crossfit or pilates? With the card you can enter selected gyms for free.
Type of cooperation
An employment contract or B2B depending on your needs.
We've prepared life insurance on great terms for you.
Recruitment process (currently run remotely)
We carefully read every CV we receive. If you meet our requirements, we call you to learn more about your skills and needs.
After talking on the phone, it's time for the technical part of recruitment, during which we can ask you to complete the task related to your position. We always provide feedback after this meeting.
The next stage is a meeting in one of our offices or online. You will have the opportunity to learn more about the team and work culture from the person who manages the department and/or Spyrosoft partner.
At Spyrosoft, we contact every person who was taking part in recruitment process. If we accept your candidacy, we will also send you a list of the next steps.