Responsibilities:
- Make the quality planning for change phase, ensure quality requirements are identified and implemented.
- Finish the quality task in the project output list. Participate in PFMEA and control plan compilation. Support the problem solving for project and change phase
- Expert in verification and process validation
- Provide quality approvals of plans, procedures, and reports for verification and validation activities
- Work with BU and sales team on customer notification about the design and process changes.
- Manage supplier deliverables on ECR/ECO, with support from sourcing/engineering/supplier quality functions
- Manages OEM-contractors and suppliers when working on process/equipment installations, modifications, and upgrades.
- Support product registration and audit from change control perspective
Qualifications:
- Bachelor or above in engineering or scientific discipline
- Fluent English speaking and writing as working language
- A minimum of 5 years of experience with quality assurance or design control, preferably in the medical devices industry.
- ISO13485/EU MDR/FDA 21 CFR 820
- Understand different cultures and can work with different regional team member