Description:
Excellent opportunity to join a thriving company with excellent professional development opportunities.
Key Responsibilities:
- Develops, modifies, applies and maintains standards for Software Quality methods, processes and procedures.
- Acts as an effective team member providing independent review and guidance on deliverables used to develop, implement and maintain IT/clinical/manufacturing/quality software.
- Acts as a subject matter expert on software validation to guide/ coach/ train project teams on effective and efficient implementation of software validation processes.
- Demonstrate mastery of the software validation processes
- Plays key role in providing full guidance and direction on acceptability of Software Quality and Validation deliverables. Demonstrate the ability to lead, acknowledge, develop, communicate & implement a validation strategy to ensure compliance.
Key Requirements:
- Level 8 Degree in Software or a relevant discipline.
- 6 years of related experience.
- People Leadership experience is a preference.
- Working knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485, CFR Part 11 for Medical Devices
- Must have good understanding of quality system requirements and how each quality system element connects
- Some experience in working with ‘Agile’ software development and validation methodologies
- Strong written and verbal communication skills