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

Bioengineering, 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