QA Software Engineer
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Medical Devices organization, based in Noord-Brabant Netherlands.
International and cross-functional Medical Devices organization with a broad portfolio of electrical devices.
ROLE DESCRIPTION
The Software QA Engineer will monitor every lifecycle phase of the software development process and ensures that the software reaches the Quality standards. The QMS should be compliant with FDA and ISO regulations.
There is also a close interaction with other project teams to guarantee that the processes followed and control mechanisms for software, hardware, data security and meet the regulatory requirements.
The Software QA Engineer must be a SME in compliance and control or regulated tools used in the QMS.
RESPONSIBILITIES
- Examine life cycle deliverables to ensure that regulations, protocols, procedures and methodologies are followed.
- Gather documentation to ensure accurate reporting
- Contribute to the development of the Validation Strategy
- Support Validation project teams
- Provide subject matter expertise during regulatory inspections and audits
- Provide GxP/ ISO / FDA compliance support during design and development of Software solutions
- Review and approve IT change control request
REQUIREMENTS
- At least 7 years of experience in CSV, systems security and control
- Experience supervising technical employees
- Good project management
- Strong experience and knowledge of 21 CFR, ISO 13485 and GAMP 5
- Ensure system lifecycle documentation accuracy
- Expertise in IT protocols related to software/hardware validation, information security, data lifecycle management
- Experience with FDA inspection practices
OTHER
Type of contract: temporary (via independent company or payroll)
Duration: At least a year (+ possible extensions or +permanent contract afterwards could be negotiated)
Starting date: ASAP
Full-time
Possibility to work partially remotely (1-2 days/ week)
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Patricia Oses Equiza.
