Responsibilities

• 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 investigate

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

Degree in Engineering (Electronics or mechanical)

Experiences

1. More than 3 years experience in quality function dealing with medical devices/IVD devices/Pharmaceutical

2. Knowledge of CE-IVDD and IVD requirement would be an added advantage

Competencies Preferred

• Strong analytical skills to detect and resolve problems
• Stong communicator; hands on; ability to execute
• Take ownership and able to work independently
• Good knowledge of ISO 9001, ISO13485, ISO14971 and 21CFR Part 820
• High energy level; positive attitude; works well under stress