V&V specialist

- Maintain the technical files of existing products: work with product and engineering teams to update software requirement (SRS), software design (SDD), traceability documents and other technical documentation.
- Create and execute new verification and validation (V&V) plans.
- Lead the creation of technical files of new products
- Work with the engineering team to update and review technical documentaition on releases of new versions
- Drive day to day verification and validation activities
- Overall improvement of quality assurance in the organization
requirements:
- Proven track record of creating and maintaining technical files for software components of regulated products (either submitted to the FDA via a 510(k), de-novo, or PMA pathways, or CE-marked via a class IIa or higher pathway).
- Deep understanding of 21CFR820 and IEC62304
- Good understanding of software systems.
- Experience working in an AGILE development environment
- Willingness to work at a high paced environment.
- Eagerness to be part of a team that's defining the future of healthcare
- Very high level of English (oral, reading and writing)
- Experience with software-as-a-medical-device is a plus
- Experience with MasterControl is a plus