Job Summary
- Implement and monitor the Supplier Quality Management (SQM) programs, processes, procedures in accordance with regulatory requirements.
- Manage SQM results and report timely to management board for taking actions to support production and achieve the company's objectives.
- Manage SQM equipment and test method to compliance with requirement. Develop new methods, set up testing for new materials to ensure the quality of incoming materials.
Essential Duties
- Implement and maintain supplier quality assurance programs, policies, processes, procedure to ensure compliance with regulatory requirement, ISO 13485, and FDA requirement.
- Control and maintain incoming inspection work instruction to ensure the received material matches with specifications.
- Develop new methods, set up testing for new materials to ensure the quality of incoming materials.
- Management and ensure all SQM equipment, methods are validated, qualification, calibrated and maintenance on time.
- Work directly with operating entities to ensure that inspections, process control analyses or audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
- Measures and confirm linkage to global business strategies.
- Follow up the supplier quality objectives and QMS result and report accurately and timely to management review board.Follow up actions required and theirs results to monitor the improvement of SQM.
- Coordinate with related parties to support all internal and external audits at site. Managing documents and records per requirement of QMS.
- Lead or participate to supplier audit / supplier evaluation.
- Support root cause analysis and corrective actions for NC / CAPA / SCAR related to suppliers.
- Support for improvement project related to suppliers.
- Other jobs will be assigned by Superior management.
** Minimum Qualification Requirements
Education
- Bachelor's degree or, equivalent of education (major Industrial System Engineering, Chemical or Material Technology preferred) and experience sufficient to successfully perform the essential functions of the job may be considered.
Experience
- 2+ years of manufacturing and engineering or related experience or work in quality function
- Understanding on Quality Management System, such as ISO 9001 and/or ISO 13485 is preferred.
- Understanding on Internal/External/Supplier Audit as ISO 9001 or ISO 13485
- Understanding on Risk assessment as ISO 14971
- Lean manufacturing, Six Sigma, QSR or related experience preferred.
Skills
- Knowledge and experience in one or more of the following areas:
- Quality assurance/manufacturing Process: risk management, statistics, math, or related engineering sciences.
- Communication with supplier and approach to problem solving.
- FMEA, PPAP, APQP, Six Sigma candidates preferred.
- Able to perform the highest level of complex testing, inspects raw materials using standard or custom tools, and conducts and reports quality assurance trends and metrics.
- Strong problem-solving ability.
- Knowledge and use of relevant PC software applications and skills to use them effectively.
- Demonstrated ability to communicate effectively both verbally and in writing
OR- An equivalent competency level acquired through a variation of these qualifications may be considered
