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 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.
Degree in Engineering (Mechanical or Electronics) or Degree in Science (Biology, Chemistry, Bio-engineering)
1. Experience in quality function dealing with medical devices/IVD devices/Pharmaceutical. with > 3 years of experience.
2. Knowledge of CE-IVDD and IVD requirement would be an added advantage with > 3 years of experience.
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 ISO 9001, ISO13485, ISO14971 and 21CFR Part 820.
High energy level; positive attitude; works well under stress.