EU MDR QA Engineer
Responsibilities:
- Experience with QMS Per ISO13485 / 21 CFR 820 and other country specific regulatory requirements for Med Devices
- Good Understanding on Design control requirements.
- As a member of product development team, represented the Quality function throughout all stages of the Product Development Process
- Experience with Risk Management processes per ISO14971
- Experience with Medical device manufacturing processes (including Process Validations - IQ/OQ/PQs)
- Experience in cleanroom manufacturing process such as packaging, labelling, IFU, carton, etc.
- Experience in handling complex projects includes multi geo, multiple cross functional teams, stakeholders etc.
- Strong project management skill to handle multi sites
- Project scoping, team building, project plan creation
- Budget plan
- Project status monitoring
- Risk management