Senior Software Engineer - CSV

Primary

• documentation - writing, maintaining, reviewing and updating validation documentation, and approving validation SOPs;
• reviewing validation data, compiling reports and contributing to internal audits and external inspections as they arise;
• proposing and implementing process upgrades and efficiency improvements;
• keeping on top of advances in the field and, in particular, updates to the regulatory requirements;
• training staff on the computerized systems in line with the relevant protocols and regulations.

What you will need:

• technical ability such as a sound knowledge of quality principles (e.g. ISO 13485) and computer system development lifecycles;
• keen attention to detail with natural curiosity and learning agility;
• good communication skills across a wide range of departments within the organization and an ability to engage with stakeholders to achieve the business objective;
• a resilient, agile nature with the excellent organizational ability to be able to prioritize your workload to meet deadlines and deliver in a constantly changing environment.

Additional

• Familiarity with Medical standards FDA requirements
• Basic Knowledge of any Programming language

Soft Skills

• Excellent documentation and Written/Verbal communication skills.
• Must be flexible, independent, and self-motivated