Software QMS (SAP) 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 QMS (SAP) Engineer will have similar responsibilities as the Software QA Engineer but he/she must have strong experience in the validation of ERP systems, particularly SAP.
The Software QMS (SAP) Engineer will participate in a challenging transition project. It will be a transition from a traditional SAP implementation to a SAP HANA Cloud Platform. The overall program is the simplification and standardization of an ERP backbone based on SAP.
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
- Technical background (ideally in computer science)
- Preferably experience in IT Software development
- At least 6 years of experience in Software Life Cycle Process Development/ Software Quality Assurance Engineer
- Experience in SAP consolidation and deployment across countries
- Must have minimum 2 years of experience in SPA validation, planning and execution
- Good knowledge maintaining a validated App
- Strong experience in 21 CFR, ISO 13485 and GAMP5
- 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 ZZP or preferrably via payroll)
- Duration: At least 1 year (+extensions/ +perm contract negotiable)
- Start date: ASAP
- Industry: Medical Devices
- FTE's: full-time
- Location: Eindhoven, The Netherlands
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.
