Senior Executive/executive, Quality Operations

6 days ago

Queenstown, Singapore ADVANCED OPHTHALMIC INNOVATIONS PTE. LTD. Full time

Manage and enforce in-house Quality Management System according to ISO13485 / MDD / MDR/ MDSAP requirements
- Review constantly the effectiveness and relevancy of SOPs, Quality Manual and Technical File
- Report to management team on the performance of the Quality Management System and Quality Improvement Plan
- Work closely with Regulatory Affairs function to develop and support international product registrations
- Support Clinical, Design Development, Marketing, Business Development and Revenue functions upon request
- Support any non-compliance with respective outsourced third-party service providers and suppliers
- Support daily operations and incidents arising from manufacturing and quality
- Participate periodic key suppliers’ audit and suppliers’ evaluation
- Keep abreast, identify changes required to meet new standards in an ever-changing regulatory environment
- Manage entire manufacturing process from purchasing to final product release to ensure adequate inventory to fulfil customers’ order
- Report monthly stock balance and COGS for each production batch
- Involve and support external and internal audits
- Perform laboratory testing to ensure product meet quality requirements
- Conduct research to provide support for the disclosure of new technologies and the subsequent filing of patents
- Lead the Annual Stock Take activity in the warehouse

**Salary**: $3,500.00 - $4,500.00 per month

**Benefits**:

- Health insurance

Schedule:

- Monday to Friday

Supplemental pay types:

- 13th month salary
- Performance bonus

Work Location: In person

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