Job Title: Senior Quality Engineer (Suppliers)

Department:Quality and Regulatory Affairs

Manager/Supervisor: Quality Eng Manager

注意事项：

Only Open to Singapore Permanent Resident with PRC citizen (if already convert to singapore citizen will not be considered)

Extensivel travelling required: Mainly between Singapore and ShenZhen, once every month, duration about 2-2.5 weeks for each trip. (This is the reason why only open to PRC SPR)

Future plan: might be relocated to shenzhen if the new branch office will be set up there. But still in planning, no guarantee on when.


Company overview:
US based MNC, supplying medical devices for diabetes treatment (insulin pump therapy).


Position overview:
This position is an integral part of Quality Department. It requires creativity, foresight and initiatives to work with other functions to ensure compliance and the accomplishment of departmental and company goals.


JOB / DUTIES / RESPONSIBILITIES

Develop and expedite quality programs with emphasis on conducting failure and hazard analysis, failure investigations and problem resolution. Examples: Complaints, CAPA’s, Production, Design Assurance with suppliers.
Provide QA Engineering support and expertise to Manufacturing, Engineering, Marketing and other company functions.
Review, edit, revise and approve all Labeling, Marketing Promotional materials, CAPAs, ECOs, new Procedures, new SOPs, Special Work Orders, Deviations, NCRs, Test Protocols, Test Reports, Validations, Tool files, FMEA’s.
Conduct failure and hazard analysis with suppliers.
Problem Solving and failure investigations with suppliers.
Lot testing, Device History Records approval and QA Lot Release with suppliers.
Regularly review suppliers’ Quality performance yield, conduct failure analysis and develop Quality yield improvement plans with suppliers.
Conduct process audit of suppliers manufacturing and testing processes to ensure compliance to company’s requirement and to prevent quality defects of products.
Develop and document Quality processes, procedures, and test methodologies.
Maintain company compliance to FDA Quality System Regulations and ISO 13485 standards.
Manage test protocol & report development for validations.
Support new product development through DHF maintenance, FMEA, verification testing.
Other duties as assigned.


JOB QUALIFICATIONS

Requirements

Knowledge / Education

BS degree in engineering, a technical or scientific discipline; or equivalent experience.

Job Experience

Minimum of 5 years of working experience in manufacturing industry, minimum 2-3 years in medical device industry.
* Minimum of 3 years in the Quality function working with QSR and ISO 13485.
Experience with FDA and ISO 13485 inspections.
Experience with PCBA, product assembly process and or testing of electronics products.

Skills / Competencies

Effective verbal and excellent technical writing skills.
Ability to communicate and work effectively at multiple levels within the organization.
Ability to organize and judge priorities.
Excels at generating and maintaining organized and accurate records.
PC skill, word processing, spreadsheet, database.