职位介绍

RESPONSIBILITIES / ACCOUNTABILITIES
• Compare global quality processes, procedures, manuals with local practices, analyse the gap and establish local documented system;
• Conduct QMS audit to CMO, key suppliers or internal audit per RB relevant manuals or applied standards.
• Prepare and organize the regular management review (quarterly or twice a year);
• Liaise and coordinate the SQC compliance activities with global responsible colleagues and implement it in device team.
• Support compliance activities about SQC.
• Maintain and drive the implementation. Scope include but not limited to:
o Design and development of device project;
o Validation and qualification;
o SOPs related to laboratory;
o CAPA/ Deviation (NCR) systems for root cause analysis and problem solving;
o Change management system and effective implementation at a local level.
o Internal audit schedule, ensuring audits are completed in a timely manner and corrective actions are closed.
o Audit CMO per schedule, CAPA follow up;
o Audit and qualification of key component supplier;
o Document control;
o KPIs associated with the device operation;
o KPIs associated with CMO/production performance;
o Training relating to the QMS;
o Management Review;
o Consumer complaints;
o Risk assessment;
o Good for Sale;
o Medical device Post Market Surveillance (PMS);
o SPC;
KEY CHALLENGES
• Work under fast moving organization, standardization and improve the QMS to be more robust and compliance to relevant regulatory standards and international standards within specific and limited timeframe.
• Maintain the effectiveness of QMS under the organization having changes all the time
Qualification, Experience, Personal Attributes
• Bachler degree or above;
• The working language in RB is English, therefore fluency in English communication is essential.
• Flexible to travel for audit, if required;
• Highly self-motivated, proactive in communication and action;
• RB is a global business, opportunity to progress and relocate internationally for career development and challenge;
5132 1832-|171 5517 6111 48• In line with RB core values, will be achievement focussed and able to work in an often-pressurised environment.