Engineer. Supplier Quality Management

** 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