European MNC with manufacturing of medical parts
Location: Ang Mo Kio Area
5 day work week
- Maintain and review (QMS) Quality Management policies, objective and procedures in accordance to regulatory standards
- Ensure site and global document management systems is relevant
- Maintain Standard Operating Procedure content and update when required
- Lead and coordinate customer feedback and investigation with internal stakeholders
- Plan site audit and maintain corrective actions (CAPA) are reporting systems and tracking
- Lead QMS audits and host external and customer auditors
- Maintain Materials Review Board (MRB) and out of control action plan (OCAP) platform to monitor issues raised
- Provide regular quality status reports to management such as suppliers KPI, CAPA and RMA and COPQ
- Prepare annual site level management review and coordinate SWOT analysis and risk assessment at site level
Requirement
- Degree / Diploma in Engineering
- 3 years of working experience in a manufacturing plant with focus in QMS and customer quality
- Familiar with ISO13485 and ISO9001 QMS
- Documentation Control and proficient in problem solving tools 7QC tools, 5Why, 8D and lean / six sigma
- Independent, team player and customer oriented
