Job Summary
Key Responsibilities
2. To Identify opportunities for process improvement in testing methodologies /tools and Implement best practices to enhance the efficiency and effectiveness of the testing process.
3. To oversee the creation and execution of automated test scripts ensuring consistency and alignment with quality standards to minimize exposure.
4. To develop/guide and mentor QA engineers in the use of the testing framework , enhancing their technical capabilities and increasing productivity.
Skill Requirements
Other Requirements
• Technical management of the risk management file for
Products or Product Families throughout their full Lifecycle
• Aids PDO related to risk deliverables, risk controls, or risk
reviews related to their Product or Product Family
• Performing timely Periodic Risk Reviews (PRR) for on-market
product.
Execution and approval of key risk management file
deliverables including: Risk Management Plan (RMP), Risk
Assessment (RACT), Risk Management Report (RMR), Clinical
Risk Benefit Analysis (cRBA), Risk Reviews (EBRR & PRR), and
Product Threshold Tables (PTT)
• Assessment of impact of proposed Product Changes, or of
unexpected unresolved issues, by Risk Reviews
• Interpreting feedback from Post-Market Surveillance, etc.
and alerting PDO to necessity of changes or action