Product Quality Engineer - Medical / Scientific Devices (Up to $4.2K)

• Participate in Design Transfer activities for the project to transition to Singapore Operations.
• Support all new product introduction (NPI)/ product transfer activities to ensure that all relevant technical procedures and requirements are met before commercial go-live.
• Provide data analysis & trending of processes & products characteristics and other feedback on current issues to the supporting functions on a regular basis.
• Manage and drive the relevant supporting functions on corrective/preventive action activities.
• Assist in the investigation & analysis and to follow-up with the relevant functions to ensure that they are addressed & closed in a timely manner.
• Ensure that the supporting functions adopt and apply valid quality tools/ statistical methods for improvement/ preventive action activities.
• Ensure that all product changes are captured by valid ECOs.
• Participate in continuous improvement activities in a cross-functional environment (e.g. Kaizen).
• Member of the internal audit team and to lead internal audit teams.
• Mentor and coach individuals and teams while resolving problems and implementing best practices.
• Maintain and comply with the requirements of ISO9001, ISO13485, FDA 21 CFR Part 820 and other applicable regulatory requirements

Requirements:

• Min Bachelor degree in Engineering or equivalent.
• Min 1 to 2 years of Product quality engineering experience in manufacturing industry 
• Good understanding of the following QMS standards - ISO9001 QMS, ISO13485 QMS and FDA 21 CFR Part 820 is strongly desirable
• Experience in medical / scientific manufacturing industry 

US MNC 

Salary range: $3.5K to $4.2K 

Interested candidates, please forward your resume to [Click Here to Email Your Resume] 

Consultant: Huang Jingsheng Kevyn (R1333338) 

Recruit Express Pte Ltd (99C4599)