QA and Operational Compliance Executive

2 weeks ago

Singapore MiRXES Pte Ltd. Full time

**QA and Operational Compliance Executive**

MiRXES is a Singapore-headquartered molecular diagnostic company with R&D, manufacturing, and clinical lab operations in Singapore, USA, Japan, and China. We specialize in microRNA technologies and the development, manufacturing, and provision of diagnostic test kits and clinical services. Our mission is to enable early disease detection and provide insights for better patient care by harnessing the power of microRNA to augment traditional testing. Our vision is to be the world’s leading developer and provider of accurate, actionable, and affordable microRNA-powered diagnostic tests.

**Job Location**: Tukang

**Job Summary**

The operations team is looking for a QA and Operation Compliance expert who will oversee the maintenance and upkeeping of quality assurance and operational compliance processes within the organization. The appointment holder will also ensure compliance and adherence to established quality requirements and regulations.

**Roles and Responsibilities**
- Quality Systems_- Maintenance and upkeep of the quality system.
- Monitoring of quality system processes to ensure compliance to standards, corporate requirements and upkeep of system health.
- Collaborate with Process Owners to set-up/improve processes to achieve compliance and excellence.
- Cross functional collaboration to ensure successful implementation/enhancements to existing processes.
- Document control.
- Drafting and review of documents.
- Assist in 1st, 2nd and 3rd party audits.
- Assist in audit actions.
- Facilitate and assist in risk management activities.
- Upkeep of quality events.
- Monitoring and control of artwork.
- Assist in vendor evaluation/reevaluation.
- Facilitate/assist in validation activities.
- Assist in design/technology transfer.
- Complaint and feedback management.
- Product Quality_
- Review of MBR.
- Review of technical documents, inclusive of QC data or technology related documents from design/technology transfer.
- Incoming and outgoing inspection.
- In-process inspection.
- Verification of returned goods.
- Equipment management.
- Quality Oversight_
- Act as a point of contact for all quality-related inquiries and issues.
- Training and Development_
- Foster a culture of quality awareness and continuous improvement throughout the organization.
- Reporting and Analysis_
- Monitoring of quality metrics to the line manager.
- Analyze data to identity trends

**Desired Skills and Competencies**
- Degree/diploma in a related Science or Engineering discipline.
- Extensive experience in quality assurance, preferably in a regulated environment would be an advantage.
- Strong knowledge of ISO 13485, CAP, and ISO 9001 standards would be an advantage.
- Good verbal communication, interpersonal and team skills.
- Results oriented, with a high level of integrity and dependability.
- Prior knowledge in qPCR, molecular diagnostics, and next generation sequencing, technology and techniques would be an advantage.

**This position is based in Singapore.

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