Essential Duties and Responsibilities:
Responsible for the commercial (human use) and R&D (Not for Human Use) batch release activities including review and approval of the finished Device History Record documentation and Certificate of Compliance issuing.
Responsible to review and approve GAMMA/ EtO sterilization documentation, LAL (Endotoxin) test documentation.
Responsible to review and approve of graphics artwork for Tyvek, Labels and relevant cartons.
Responsible to approve production/R&D work orders in ERP
Responsible to review and approve of samples/R&D (not for human use) batch release including review and approval of the finished Device History File documentation and Certificate of Compliance issuing.
Initiate Nonconforming Product in SAP related to finished batch release and sterilization processes
Support preparations for periodical management reviews
Participation in external audits (notified body and customers)
Write and update quality system procedures
Support QA dept activities- customer complaints, QA monthly report, KPIs, etc.
Education: Practical Eng./ Technical/BA Education– an advantage
Minimum 2 years working in quality assurance– an advantage
Relevant work history and/or experience may be considered in lieu of above required qualifications
Experience in the medical device or pharma industry- an advantage
Excellent written and oral communication skills
Ability to work independently, multi-task and thrive in fast-paced environment
Proficient in Microsoft Office Suite including Word, Excel, and Power Point
Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
Able to comply with the companys safety policy at all times.
