Reporting to QA Director, you will lead and manage the QA and Customer Service teams, providing on-time solutions to resolve customer complains;
Defining Customer Service Process and correcting misleading behaviors
Familiar with ISO 13485, QSR system, good at handling RMA
Control Quality issues and activities during product production
Ability to participate in quality audits, as needed
Support programs in combination biologic / device platforms. Provide compliance oversight to Medical Device regulations and QSRs
Independently provide quality leadership and oversight activities to project teams and day-to-day cGMP manufacturing and testing for clinical trial material
Redefining proper policies or SOPs to improve production Quality and product Quality
Utilize risk management and failure analysis proactively to anticipate events and implement mitigation.
Audit suppliers, ensuring production outputs are met with correct inputs
Candidate Profile :
8+ years’ QA experience in Medical Device Manufacturing business with at least 3 years in managerial level.
Master or above degree in Biotech, Engineering, Chemistry, or other related fields.
Must be fluent in English with good cross-functional communication skills.
QA related certificate is a plus