Perform QMS audit to vendors within scope of medical device, drug product, cosmetic product and lab, write audit report, and follow-up supplier CAPA.
Work as project leader in Vendor FDA project, supervise vendor to adequately establish and maintain QMS based on 21CFR820 or 21CFR210&211, and support vendor for FDA audit, act as consultant to help vendor establish a better QMS with professional suggestions.
Monitor vendors’ quality management system with proper visiting in key vendor FDA projects, identify their QMS problems under regular review.
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Develop test plan, define tool requirements, testability, risk assessment, effort estimation, test team organization in a project and schedule, design test cases, write and execute test cases, log test results and defects, prepare test summary test reports, review test artefacts, perform defect analysis.
Responsible to create test specification that covers test cases, pre-conditions, inputs data and expected output data.
Setup and maintain test environment. Work with the project/application team to ensure test environment setup are in accordance to the test and customer requirements.
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As a QA Team Lead you will design and build systems that embed quality into the development lifecycle rather than treating it as a final step. This is a hands-on leadership role working closely with product, design, and engineering to define quality ownership across squads while contributing directly through automation, tooling, and observability. Over time you will help establish and grow a scalable quality engineering function that supports the organisation as it scales.
As a QA Team Lead you will design and build systems that embed quality into the development lifecycle rather than treating it as a final step. This is a hands-on leadership role working closely with product, design, and engineering to define quality ownership across squads while contributing directly through automation, tooling, and observability. Over time you will help establish and grow a scalable quality engineering function that supports the organisation as it scales.
Develop, decompose, and implement departmental quality objectives; supervise and evaluate the performance and daily work of subordinate quality engineers.
Monitor work progress through regular meetings and report reviews; assign tasks and provide technical guidance and support to team members.
Organize and deliver departmental training programs to enhance quality awareness, professional competence, and compliance knowledge within the team.
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Document Control: Maintain and control QA documents, records, and filing systems (issuance, revision, distribution, archiving, and retention) in accordance with Integrated Management System (IMS) procedures.
Management System Support: Maintain and update documentation/records related to ISO 9001, FSSC 22000, ISCC PLUS, SMETA, as well as calibration and verification activities.
Audit Administration & Coordination: Assist in preparing documents and records for internal, external, customer, certification, and regulatory audits.
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