Our client is seeking to hire Product Quality Engineer to join their team.

This role is a constructive step forward for anyone looking for excitement and challenges at work.

The exciting opportunity can be yours, if you have the following qualities and skills:

• Degree in Engineering (Mechanical or Electronics) or Degree in Science (Biology, Chemistry, Bio-Engineering).
• Minimum of 3 years in quality function dealing with medical devices/IVD devices/Pharmaceutical.
• Knowledge of CE-IVD and IVD requirement would be an added advantage.
• Experience with GMP and ISO13485 environment.

 

The responsibility of this role encompasses:

• 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 objective, 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

1. Customlaer compints / feedback,

2.  Product quality trend and address product issues,

3.  Feedback and support supplier quality and on product complaint investigation related suppliers.

4.  Drive on-going product improvement activities.

5.  Chair PQT (Product Quality Team) monthly meeting.

• Ensure the quality systems and procedures are in compliance with ISO9001, ISO13485, ISO14791, QSR21CFR and OHSAS18001 requirements.
• Manage quality escalation issues and support plant-wide activities and special projects, as assigned.
• Support cost reduction initiatives and participate in evaluation and qualification of material and process.

An exciting career awaits the right candidate! Click “Quick Apply” to register your interest now.

All applicants’ CV will be treated with the strictest confidentiality. We regret to inform that only shortlisted candidates will be contacted.