Quality Assurance Executive

5 days ago

Singapore CorDx Full time

**Responsibilities**:

- Implement, manage and constantly improve the company’s quality management system, including but not limited to the IVD products and equipment.
- Perform incoming, in-process and final QC inspection.
- Regularly perform internal audits, compile audit reports, problem analysis reports, improvement proposals, and monitor the rectification plan and its implementation.
- Lead and Participate in the internal audits and management reviews of the company's quality system as key member of company's quality department.
- Manage the system and documents of company’s quality management system, including but not limited to the IVD products and equipment.
- Be specifically responsible for the IVD equipment quality management system.
- Statistical analysis of IVD equipment quality data, and draft reports and corrective and preventive measures.
- Update quality standards, laws and regulations and publish company quality policy.
- Establish collaborative and cooperative working relationship with key opinion leaders and the regulatory bodies.
- Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.
- Any other ad-hoc duties or projects as required by the management team.

**Requirements**:

- Majoring in biology, medicine, laboratory science, immunology, pharmacy or quality engineering are preferred.
- A bachelor's degree with 2 years of relevant experience, others are welcome to apply.
- Quality system related training and internal auditor training.
- Familiar with US FDA 820 & ISO13485 quality management system and ISO 13485 certification work, experience with successful case(s) will be preferred.
- Familiar with medical device industry standards and specifications.
- Strong quality management system knowledge and capabilities.
- Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc.
- Familiar with IVD product development and commercialization life cycle.
- Systematically project management, good planning, execution and timely communication. Good presentation skills.
- Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player.
- Meticulous and strong sense of responsibility; able to handle stress and tight schedule.

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