General Be a part of extended project team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
Develops understanding of Design Controls, Risk Management and Usability for Medical Devices.
Supports departmental, functional, and divisional Design Quality goals and priorities.
Executes methodologies to meet individual and team objectives effectively.
Execute methodologies such as Statistical Analysis, Risk Management, and Root Cause Analysis in support of project activities.
Apply critical thinking and engineering analysis to solve problems.
CAPAs, VIPs, and regulatory requirement changes.
Analytical and problem-solving abilities.
Analyses, draws conclusions and makes appropriate decisions from risk management activities and test data.
Minimum of a Honours bachelor's degree (Level 8) in engineering (Biomedical, Mechanical, Electrical, etc.) or equivalent fields of study.
2+ years of experience in design assurance or a related field, or a combination of education and experience to perform at this level.
Knowledge of key regulatory requirements, including ISO Risk Management), 21 CFR 820 (US QS Regulation), ISO Quality Management Systems).
Understanding of Quality tools and methodologies with an emphasis on Design Controls and Risk Management.
Working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards.
Strong technical knowledge, problem-solving abilities, collaborative mindset, and effective communication skills.
Experience with Post Market Surveillance, EU MDR, and IEC Usability).
Ability to work independently and as part of a team.