Supplier Quality Engineer

Summary

• Participates in Supplier Quality Management Program, which includes the Approved Supplier List (ASL) Management, Supplier On-boarding Process, Supplier Change Management, Supplier Quality Agreement Review, Supplier Corrective Action System, and Supplier Performance and Audit Evaluation.
Achieving of such will require communicating and effecting creative solutions on internal and external stakeholders. This is to ensure that all products that customers received are at their best quality.

Roles and Responsibilities

• To participate in procedures for Supplier Management process such as supplier on-boarding, selection and approval process by assessing and evaluating supplier profile; visiting and auditing of supplier facility and process, initiating supplier quality agreement review, and establishing good partnership with suppliers.
• To develop and manage the ASL across entities and ensure proper measurement and monitoring framework tailored for each supplier category.
• To evaluate and monitor supplier performance and business risk evaluation on the Quality, Delivery and Service aspects, and collaboration with suppliers to identify opportunities for enhancements and improvements.
• To participate in supplier related changes through the Supplier Change Management process, and evaluate the change with internal stakeholders via the initial change notice form and impact assessment/FMEA risk management.
• To support new product development launches and/or new supplier/material qualification by ensuring that all supplier on-boarding related documentations and action are complete, and that quality of purchased material meets the required standards and expectations.
• To communicate and work closely with external suppliers and internal stakeholders (Supply Chain, Incoming Material Engineering, Manufacturing, R&D, and Regulatory Affairs) on supplier/material qualification related projects, material quality related issues. To address on purchased material failures/defects and derive proper preventive and corrective action plans through SCAR system. Additionally, to gather information from both parties to support the flow of information and identify/support process enhancements and improvements.
Internal audits of internal quality procedures

Requirement

• Bachelor of Engineering or Bachelor of Science in Bioengieering, Materials, or general Engineering relevant to medical fields
• Preferred to have 1-2 years of relevant experience in Quality Assurance, Supplier Management, or medical device/manufacturing environment.
• Preferred to have expertise and knowledgeable in applicable standards (such as ISO 13485, Regulation (EU) 2017/745, ISO 9001, 21 CFR 210/211/820, etc) or expertise/certified in QMS/Lead/Internal Auditor preferably in ISO 13485/9001 or equivalent
• Working knowledge in FMEA
• Very organized and in good documentation management
• Excellent Interpersonal and communication skill to build cross-functional teamwork and support, Good capbilities with dealing of suppliers
• Possess positive working attributes and comfortable to manage admin processes and ad-hoc assignments