Operating Hours: Mon-Fri, 8am-515pm

Location: Walking distance to Joo Koon MRT station

Reporting to: Quality Manager

 

Responsibilities and Authorities

• Drive product improvement activities to ensure customer satisfaction and ensure compliance to site quality management system.
• Develop, implement and coordinate quality programs, including tracking, analyzing, reporting and problem solving.
• Work with cross-functional teams to ensure a successful and high quality product release.
• Supports company goals and objectives, policies and procedures in compliance with quality systems, cGMP and FDA regulations.
• Lead sustaining activities with current products to determine top issues in field and drive improvements to reduce product issues. This includes review and investigation of:

a) customer complaints/feedback,

b) product quality trend and address product issues.

c) Feedback and support supplier quality and on product complaint investigation related to suppliers.

d) Drive on-going product improvement activities

e) Chair PQT monthly meeting.     

• Ensure that system and procedure are in compliance with ISO9001, ISO14001, ISO13485, ISO14971, OHSAS 18001 and FDA 21 CFR Part 820 requirements
• Engaging in design reviews and new product qualification activities to ensure customer specified quality and reliability requirements are met.
• Manage quality escalation issues.
• Support cost reduction initiatives as participates in evaluation and qualification of material and process
• Evaluate product return and drive failure for investigation.
• Support plant-wide activities and special projects, as assigned.

Qualification required

• Degree in Engineering or Science 

Experience required

• More than 3 years experience in quality function dealing with medical devices/IVD devices
• Knowledge of CE-IVDD and IVD requirement would be an added advantage
• ISO13485 knowledge 
• GMP cleanroom environment experience
• Sterilization experience 
• Validation experience 

Competencies Preferred

• Strong analytical skills to detect and resolve problems
• Strong communicator; hands on; ability to execute
• Take ownership and able to work independently
• Good knowledge of any of the following: ISO 9001, ISO14971 and FDA 21CFR Part 820
• High energy level; positive attitude; works well under stress