Main Responsibilities and Accountabilities:
1. Serve as Medical Device and Packaging QA Associate on assigned combination product development projects. Work with project leaders and both internal and external team members to ensure that all design development work meets applicable FDA, EU MDR, and other global regulatory requirements. Ensure that design development teams follow the Design Controls process and utilize appropriate quality engineering techniques such as risk analysis, statistical data analysis, sampling plan development, etc.
2. Ensure external medical device development and manufacturing partners meet the standards and criteria set by CSL. Support vendor management activities by participating in the audits; reviewing quality or development agreements; monitoring vendor performance.
3. Provide regular progress reports and escalate potential risks related to Quality System and/or project status to Quality management and stakeholders.
4. Assist with development and implementation of the quality system compliant with 21 CFR Part 4, MDR and other global requirements. As assigned, propose improvements to the existing processes, update SOPs / WIs / Forms, develop and conduct training on the modified processes.
5. Stay abreast of changing regulatory requirements for medical device and combination products.
6. Maintain systems / databases related to the combination products, as assigned. Examples may include Applicable Standards List, vendor certificate database, test method validation log.
7. Able to conduct root cause analysis and problem solve issues with recommendations.