About this role
<p><strong>Responsibilities: </strong></p> <ul> <li style="font-size:10.0pt"><span style="font-size:10.0pt;font-family:verdana, geneva, sans-serif">Participate in new product development and project design change for global products. </span></li> <li style="font-size:10.0pt"><span style="font-size:10.0pt"><span style="font-family:verdana, geneva, sans-serif">Participate and provide independent oversight on project/ design changes deliverables; review and ensure that project/validation documents comply to regulatory requirements and quality</span>.</span></li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt"><span style="font-family:verdana, geneva, sans-serif;font-size:10.0pt">Handle change control, especially be the expert in process validation for global products.</span></li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt"><span style="font-family:verdana, geneva, sans-serif;font-size:10.0pt">Participate in the critical quality issue which required QAE attention in the project as required.</span></li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt"><span style="font-family:verdana, geneva, sans-serif;font-size:10.0pt">Involve in NCR/ CAPA activities as required.</span></li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt"><span style="font-family:verdana, geneva, sans-serif;font-size:10.0pt">Maintain the Risk Management files and initiate Process Risk Evaluation during new platform project/ design change.</span></li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt"><span style="font-family:verdana, geneva, sans-serif;font-size:10.0pt">Other QM R&D function, as identified.</span></li> </ul> <p> </p> <p><strong>Requirements:</strong></p> <ul> <li>Degree in science or equivalent.</li> <li>Min 2 years in Quality Assurance or Quality Engineering.</li> <li>Knowledge in ISO13485 and ISO14971.</li> <li>Experience in product development, project management and/or design control.</li> <li>Innovative, committed with good accountability.</li> </ul>