Job Description

Ensure compliance with Design Control and Risk Management activities and processes, managing and completing Quality deliverable for R&D projects.
Provide Quality support and guidance to R&D project leads and team members, and direct Design Quality Engineers and Quality Engineers.
Resolve project issues through collaboration with team members, suppliers, and other stakeholders, applying systematic problem-solving methodologies.
Manage and maintain records related to design control projects, participate in design review meetings, and generate risk management file documents.
Develop and review protocols and reports for sterilisation, bio-compatibility, and packaging validations, as well as review and approve R&D batch details and production records.
Monitor data from Quality Management systems, provide immediate feedback on deviations or issues, and lead or facilitate compliance and improvement activities (e.g., CAPA/non-conformance).

Must Have

5/8 years of experience in roles
Experience within Quality Assurance for medical devices in R&D including Validation, Design and Risk Management (see details below) Design Control
Experience in project management
Independent and accountable, able to work on project, efficient communication

Details need it

* Experience with Validation including method validation and test validation

* Experience with Design Phase in design control and design quality

* Experience with Risk Management, familiar with RA standards for QA (any region)