Quality Assurance and Regulatory Affairs Manager
INTERNATIONAL DIAGNOSTICS COMPANY LIMITEDToday
Full Time
3 - 5 Year
Bangkok
Bachelor's Degree
40,000 - 80,000 baht/month
Summary
The Quality Assurance Manager will be responsible for maintaining an overall of quality standards under ISO13485 and ISO15189:ISO15190 through the process of production, incoming materials inspection, checking and contracting maintenance and calibration of all available laboratory equipment under regulatory standards.
Responsibilities
- Monitor and control the overall picture of Quality Department.
- Maintain and control all documentation, assigning tasks to the team and monitor the process.
- Control quality of production process as well as product through QC process.
- Confirm specifications by conducting visual and measurement tests on materials.
- Inspect quality of incoming materials through the incoming process after receiving the materials from the key contact person of the purchase.
- Plan, maintain and record documentation regarding maintenance and calibration.
- Perform calibration and maintenance of available equipment under ISO standards.
Qualifications
- Bachelor’s degree or master's degree in science or medical field or related field.
- 4-5 years of experience in QA/ QC, laboratory or medical devices is preferred.
- Experience or have background knowledge of ISO standards is a must.
- Strong communication skills, in both written and verbal.
- Efficient English in both verbal and written is a must.
- Highly organized with strong ability to prioritize across projects.
- Collaborative team-player.
- English Class Provided
- Staff training and development
- 5-day work week
- Social security
- Health insurance
- Accident Insurance
- Ordination leave
- Performance/results-based bonus
INTERNATIONAL DIAGNOSTICS COMPANY LIMITEDAbout International Diagnostics
International Diagnostics provides next-generation immunodiagnostic tools for pathology and cytology laboratories. Our portfolio includes our patented hMX rare-cell separator, our single-cell Cryoimmunostaining suite, as well as advanced fluorescence scanning and AI-powered image acquisition and analysis tools.
We empower cytologists to harness the full potential of atypical cell diagnostics of the human body - starting from improved routine cytology diagnostics all the way to cancer rare-cell detection from patients’ blood.
We were Mahidol University’s first spin-off company and are now headquartered in Singapore with offices in Thailand, Germany and the US. Our global team adheres to our four core values Curiosity, Ambition, Responsibility and Equality (CARE).
Location241/1 ซอย อาคารพิบูลวัฒนา ถนน พระรามหก แขวง พญาไท เขต พญาไท กรุงเทพมหานคร 10400
Contact personTanapat Apavira
Telephone0-2087-8499, 08-3061-4468
Website
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