European MNC with manufacturing and R&D operations presence
- Responsible for full spectrum of Quality function in a medical part manufacturing operations with QC laboratory support
- Lead a team of Engineers, Technicians and Inspectors within the quality department
- Maintain and ensure operations’ QMS in compliance with ISO 13485 and ISO 9001 and other regulatory standard
- Involvement with Quality Operations in area of quality control and assurance leading to products output and specifications meeting customers standard and requirement
- Maintain stringent quality lab resting protocols and safety standards
- Manage and plan capital equipment expenditure and control annual budget for sustaining and expansion purposes
- Involve in NPI and quality engineering work with internal stakeholders on new / existing product development to ensure compliance and production readiness
- Collaborate with Global Quality team to align and drive global initiatives
- Lead and prepare for all internal and external audits from customers to regulatory bodies
- Supplier quality management through audits, reviews and partnership management
- Continuously seek quality improvement initiatives through projects formation to increase manufacturing efficiency and reduce product quality issues
- Work closely with manufacturing, engineering, R&D and procurement on operations non-conformance, identifying root causes and follow up with sustainable corrective actions
Requirement
- Degree / Masters in Engineering
- Minimum 10 years of working experience in quality engineering management in a MNC manufacturing environment with proven people leadership
- Knowledge of ISO13485 and ISO9001 and understanding of validation and verification processes for medical parts manufacturing
- Display strong knowledge and application of problem solving tools: SPC, Six Sigma, Lean principles
- Experience handling multiple projects with internal and external stakeholders
- Individual to be analytical, attention to detail, high integrity and proactive
