- Kampung Batu Kawan Simpang Ampat Pulau Pinang Malaysia 14110

工作地点
职位描述
任职资格
Bachelor’s degree in an Engineering discipline or related field of study. 2+ years of experience in Quality, QA or related medical device experience. Knowledgeable in Quality System Regulations, Medical Device Regulations, ISO 13485 Quality Standards and FDA 21 CFR Part 820 and FDA 21 CFR Part 11
岗位职责
The Field Staff shall perform the following duties and responsibilities for the Company:
1.Review and approve all Equipment Qualification documentations.
2.Work with cross functional team to resolve quality issues related to non-device software and any discrepancies occur during qualification.
3.Ensuring compliance company procedures, applicable regulatory requirements and industry standards.
4.Support other Software Quality related processes such as non-device software related NCEP/CAPA, and risk management. Participate in meetings and discussions related to non-device software validation.
好处
所需技能
重要安全守则
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